Trial Title:
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT ID:
NCT05633615
Condition:
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Transformed Follic Lymph to Diff Large B-Cell Lymphoma
Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Cyclophosphamide
Fludarabine
Axicabtagene ciloleucel
Tisagenlecleucel
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antibodies, Bispecific
Immunoconjugates
Polatuzumab vedotin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Axicabtagene Ciloleucel
Description:
Given IV
Arm group label:
Step I (lymphodepleting chemotherapy)
Other name:
KTE C19
Other name:
KTE-C19
Other name:
KTE-C19 CAR
Other name:
Yescarta
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood and tissue samples
Arm group label:
Step II Arm I (mosunetuzumab)
Arm group label:
Step II Arm II (polatuzumab vedotin)
Arm group label:
Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Arm group label:
Step II Arm IV (observation)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET-CT or CT
Arm group label:
Step II Arm I (mosunetuzumab)
Arm group label:
Step II Arm II (polatuzumab vedotin)
Arm group label:
Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Arm group label:
Step II Arm IV (observation)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Given IV
Arm group label:
Step I (lymphodepleting chemotherapy)
Other name:
(-)-Cyclophosphamide
Other name:
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Other name:
Carloxan
Other name:
Ciclofosfamida
Other name:
Ciclofosfamide
Other name:
Cicloxal
Other name:
Clafen
Other name:
Claphene
Other name:
CP monohydrate
Other name:
CTX
Other name:
CYCLO-cell
Other name:
Cycloblastin
Other name:
Cycloblastine
Other name:
Cyclophospham
Other name:
Cyclophosphamid monohydrate
Other name:
Cyclophosphamide Monohydrate
Other name:
Cyclophosphamidum
Other name:
Cyclophosphan
Other name:
Cyclophosphane
Other name:
Cyclophosphanum
Other name:
Cyclostin
Other name:
Cyclostine
Other name:
Cytophosphan
Other name:
Cytophosphane
Other name:
Cytoxan
Other name:
Fosfaseron
Other name:
Genoxal
Other name:
Genuxal
Other name:
Ledoxina
Other name:
Mitoxan
Other name:
Neosar
Other name:
Revimmune
Other name:
Syklofosfamid
Other name:
WR- 138719
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Given IV
Arm group label:
Step I (lymphodepleting chemotherapy)
Other name:
Fluradosa
Intervention type:
Biological
Intervention name:
Lisocabtagene Maraleucel
Description:
Given IV
Arm group label:
Step I (lymphodepleting chemotherapy)
Other name:
Anti-CD19-CAR Genetically Engineered Autologous T Lymphocytes JCAR017
Other name:
Anti-CD19-CAR Genetically Engineered Autologous T-lymphocytes JCAR017
Other name:
Autologous Anti-CD19-EGFRt-4-1BB-zeta-modified CAR CD8+ and CD4+ T-lymphocytes JCAR017
Other name:
Breyanzi
Other name:
JCAR 017
Other name:
JCAR017
Intervention type:
Biological
Intervention name:
Mosunetuzumab
Description:
Given IV
Arm group label:
Step II Arm I (mosunetuzumab)
Arm group label:
Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Other name:
Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A
Other name:
BTCT 4465A
Other name:
BTCT-4465A
Other name:
BTCT4465A
Other name:
CD20/CD3 BiMAb BTCT4465A
Other name:
RG 7828
Other name:
RG-7828
Other name:
RG7828
Other name:
RO7030816
Intervention type:
Other
Intervention name:
Patient Observation
Description:
Undergo observation
Arm group label:
Step II Arm IV (observation)
Other name:
Active Surveillance
Other name:
deferred therapy
Other name:
expectant management
Other name:
Observation
Other name:
Watchful Waiting
Intervention type:
Drug
Intervention name:
Polatuzumab Vedotin
Description:
Given IV
Arm group label:
Step II Arm II (polatuzumab vedotin)
Arm group label:
Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Other name:
ADC DCDS4501A
Other name:
Antibody-Drug Conjugate DCDS4501A
Other name:
DCDS4501A
Other name:
FCU 2711
Other name:
polatuzumab vedotin-piiq
Other name:
Polivy
Other name:
RG7596
Other name:
Ro 5541077-000
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET-CT
Arm group label:
Step I (lymphodepleting chemotherapy)
Arm group label:
Step II Arm I (mosunetuzumab)
Arm group label:
Step II Arm II (polatuzumab vedotin)
Arm group label:
Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Arm group label:
Step II Arm IV (observation)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Biological
Intervention name:
Tisagenlecleucel
Description:
Given IV
Arm group label:
Step I (lymphodepleting chemotherapy)
Other name:
CART-19
Other name:
CART19
Other name:
CTL019
Other name:
CTL019 T-cells
Other name:
Kymriah
Other name:
Tisagenlecleucel-T
Summary:
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by
chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come
back (recurrent) or that does not respond to treatment (refractory) or grade IIIb
follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the
ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody,
called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted
therapy because it attaches to specific molecules (receptors) on the surface of cancer
cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and
cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune
system cell) are changed in the laboratory so they will attack cancer cells. T cells are
taken from a patient's blood. Then the gene for a special receptor that binds to a
certain protein on the patient's cancer cells is added to the T cells in the laboratory.
The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T
cells are grown in the laboratory and given to the patient by infusion for treatment of
certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and
CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not
giving them.
Detailed description:
PRIMARY OBJECTIVES:
I. To compare the progression-free survival in participants with relapsed/refractory
large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD) or partial
remission (PR) on first imaging response by central review (day +30 positron emission
tomography [PET]/computed tomography [CT] scan) after commercial CD19 CAR T-cell therapy
who are randomized to receive each consolidation therapy versus those that receive no
consolidation therapy (i.e. control).
Ia. Specifically, to compare the progression free survival (PFS) of 1) mosunetuzumab
consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation.
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) in participants randomized to each consolidation
treatment arm versus control.
II. To compare the complete remission (CR) conversion rate up to one year in participants
randomized to each consolidation arm versus control.
III. To evaluate the treatment-related adverse events in participants randomized to each
consolidation arm.
IV. To evaluate the association between total metabolic tumor volume (TMTV), standardized
uptake value (SUV) max, and sum product (SPD) of diameters by PET-CT at first imaging
response with complete remission conversion up to one year in participants randomized to
each consolidation arm as well as those randomized to control.
V. To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
randomized to Arm 4 (observation) who have lymphoma progression within 12 months of CAR
T-cell infusion and subsequently 'cross-over' to receive treatment with mosunetuzumab +
polatuzumab vedotin.
VI. To estimate overall survival for all patients registered to this study. VII. To
assess the difference in overall survival between participants who achieved CR at first
imaging (day +30) versus those who did not achieve CR at first imaging.
BANKING OBJECTIVES:
I. To bank specimens for future correlative studies. II. To bank PET-CT images for future
correlative studies.
OUTLINE:
STEP I: Patients receive lymphodepleting chemotherapy consisting of fludarabine
intravenously (IV) and cyclophosphamide IV on study. Patients then receive
tisagenlecleucel IV, axicabtagene ciloleucel IV, or lisocabtagene maraleucel IV on study.
STEP II: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT
and undergo collection of blood and tissue samples throughout the study.
ARM II: Patients receive polatuzumab vedotin IV on study. Patients also undergo PET-CT
and/or CT and undergo collection of blood and tissue samples throughout the study.
ARM III: Patients receive polatuzumab vedotin IV and mosunetuzumab IV on study. Patients
also undergo PET-CT and/or CT and undergo collection of blood and tissue samples
throughout the study.
ARM IV: Patients undergo observation on study. Patients also undergo PET-CT and/or CT and
undergo collection of blood and tissue samples throughout the study. Patients with
subsequent progression within 12 months of CAR T-cell therapy may crossover to Arm III.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of
diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal
large B-cell lymphoma (PMBCL)
- STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed
DLBCL from follicular or marginal zone lymphoma
- STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic
disease (at least one lesion with longest diameter > 1.5 cm)
- STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS)
lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must
be asymptomatic from their CNS disease
- STEP 1: REGISTRATION: Participants must be registered for step 1 after they have
signed institutional consent for CAR T-cell leukapheresis but prior to the start of
lymphodepleting (LD) chemotherapy for commercial CAR T-cell product
- STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must
be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food
and Drug Administration (FDA) approved commercially available CD19 CAR T-cell
construct.
- Participants must qualify for commercially approved CD19 CAR T-cell therapy per
FDA package insert.
- If the CAR T-cell product does not meet parameters to be given as an FDA
approved product (i.e. does not meet specification criteria mandated by FDA and
is infused under an expanded access protocol [EAP] or single participant
investigational new drug [IND]) the participant will be taken off of study and
no longer be eligible for step 2 randomization
- STEP 1: REGISTRATION: Participants are permitted to receive or have received
'bridging therapy' after CAR T-cell leukapheresis. However, participants must not
receive polatuzumab vedotin, and/or mosunetuzumab as part of bridging therapy.
- Bridging therapy is defined as lymphoma directed therapy administered between
leukapheresis and the start of LD chemotherapy. This includes cytotoxic
chemotherapy (e.g.: bendamustine and rituximab [BR], rituximab, gemcitabine and
oxaliplatin [R-gem/ox]), radiation, corticosteroids, as well as novel therapies
such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.:
lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab,
tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint
inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.
- If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they
will ineligible to continue on step 1 registration portion of the study and be
ineligible for step 2 randomization
- STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days
prior to the start of LD chemotherapy.
- All pre-CAR T-cell therapy disease must be assessed and documented on the
baseline/pre-registration tumor assessment form.
- If receiving bridging therapy, participants must have a PET-CT scan upon
completion of all planned bridging therapy. If the PET-CT scan after completion
of bridging therapy is consistent with complete remission per Lugano criteria
as determined by enrolling physician, that participant will be ineligible for
step 2 randomization.
- Participants are permitted to receive corticosteroids after leukapheresis
without the need to repeat a PET-CT scan. If steroids are used, they must be
planned to stop no later than 3 days before CAR -T cell infusion.
- If response assessment by central review cannot be completed (I.e., poor
quality of PET-CT scan, PET-CT performed out of window, etc.) this would be
recorded as 'inadequate assessment' and patient would not be eligible for
randomization
- STEP 1: REGISTRATION: Participants that have previously been treated with
polatuzumab vedotin or mosunetuzumab prior to CAR T-cell leukapheresis for either
indolent or aggressive NHL are eligible as long as the participant did not have
refractory disease or progression/relapse within 6 months of the last infusion with
either agent
- STEP 1: REGISTRATION: Participants must be planning to receive CAR T-cell infusion
no earlier than 2 days and no later than 14 days after completion of the last day of
lymphodepleting chemotherapy. Any participant receiving CAR T-cell infusion outside
of this window will be ineligible for step 2 randomization
- STEP 1: REGISTRATION: LD chemotherapy prior to CAR T-cell infusion must be planned
to start within 60 days after step 1 registration
- STEP 1: REGISTRATION: Participants must be >= 18 years of age at the time of
registration
- STEP 1: REGISTRATION: Participants must have Zubrod performance score (PS) of 0, 1,
or 2
- STEP 1: REGISTRATION: Total bilirubin =< 2 x institutional upper limit of normal
(ULN) (within 14 days prior to registration)
- Unless due to Gilbert's disease or lymphomatous involvement of liver
- STEP 1: REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) =< 3 x institutional ULN (within 14 days prior to registration)
- STEP 1: REGISTRATION: Creatinine clearance >= 40 mL/min, as estimated by the
Cockcroft and Gault formula. The creatinine value used in the calculation must have
been obtained within 14 days prior to registration. Estimated creatinine clearance
is based on actual body weight
- STEP 1: REGISTRATION: Participants must have an echocardiogram (ECHO) or multigated
acquisition scan (MUGA) within 60 days prior to registration with a cardiac ejection
fraction >= 40%.
- Participants with current symptoms of cardiac disease must have a clinical risk
assessment of cardiac function using the New York Heart Association Functional
Classification. To be eligible for this trial, participants must be class 2B or
better.
- Participants must not have documented myocardial infarction and percutaneous
coronary intervention (PCI) within 6 months prior to registration or myocardial
infarction without PCI within 3 months of registration, or unstable angina
- STEP 1: REGISTRATION: Participants with peripheral neuropathy must have < grade 2
- STEP 1: REGISTRATION: Participants with hepatitis B virus infection must have
undetectable viral load within 14 days prior to registration, be on suppressive
therapy and have no evidence of hepatitis B virus (HBV) related hepatic damage
- STEP 1: REGISTRATION: Participants with hepatitis C infection must have eradication
therapy completed, have no evidence of hepatitis C infection (HCV) related damage
and have undetectable viral load within 14 days prior to registration
- STEP 1: REGISTRATION: Participants with known human immunodeficiency virus
(HIV)-infection must be on effective anti-retroviral therapy at time of registration
and have undetectable viral load test on the most recent test results obtained
within 6 months prior to registration
- STEP 1: REGISTRATION: Participants must be offered the opportunity to participate in
banking for planned translational medicine and future research. With participant
consent, any residuals from the mandatory tissue submission will also be banked for
future research.
- Note: Streck tubes must be ordered in advance. Please allow 5-7 days for
shipment of the collection kits
- STEP 1: REGISTRATION: NOTE: As a part of the OPEN registration process the treating
institution's identity is provided in order to ensure that the current (within 365
days) date of institutional review board approval for this study has been entered in
the system.
- Participants must be informed of the investigational nature of this study and
must sign and give informed consent in accordance with institutional and
federal guidelines.
- For participants with impaired decision-making capabilities, legally
authorized representatives may sign and give informed consent on behalf of
study participants in accordance with applicable federal, local, and
Central Institutional Review Board (CIRB) regulations
- STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for step
1 registration
- STEP 2: RANDOMIZATION: Participant's CAR T-cell product must have met specification
parameters to be given as an FDA approved commercial product
- STEP 2: RANDOMIZATION: Participants must have a PET-CT scan between days 25-40 after
CAR T-cell infusion and determined to have a response consistent with stable disease
or partial remission by central review compared to most recent pre-LD chemo/CAR
T-cell PET-CT scan.
- Note: Patients with delayed enrollment > 21 days after 'day +30' PET-CT scan
will necessitate a repeat PET-CT scan if concerning signs or symptoms of
lymphoma progression develop.
- Note: If response assessment by central review cannot be completed (I.e., poor
quality of PET-CT scan, PET-CT performed out of window, etc.) this would be
recorded as 'inadequate assessment' and patient would not be eligible for
randomization
- STEP 2: RANDOMIZATION: Eligible participants must be randomized no later than 60
days after CAR -T infusion
- STEP 2: RANDOMIZATION: Participants must have started LD chemotherapy within 60 days
of signing consent for step 1 registration
- STEP 2: RANDOMIZATION: Participants must have S2114 CAR T-cell therapy form
submitted to Southwest Oncology Group (SWOG) prior to step 2 randomization
- STEP 2: RANDOMIZATION: Participants must have had a PET-CT scan upon completion of
all planned bridging therapy if received, with the exception of up to 7 days of
corticosteroids. If the PET-CT scan after completion of bridging therapy was
consistent with complete remission per Lugano criteria as determined by enrolling
physician, that participant will be ineligible for step 2 randomization.
- If response assessment by central review cannot be completed (I.e., poor
quality of PET-CT scan, PET-CT performed out of window, etc.) this would be
recorded as 'inadequate assessment' and patient would not be eligible for
randomization
- STEP 2: RANDOMIZATION: Participants must have Zubrod PS of 0, 1, or 2
- STEP 2: RANDOMIZATION: Absolute neutrophil count (ANC) >= 1.0 x 10^3/uL and
participants must not have received myeloid growth factor within 72 hours prior to
this lab being drawn (within 7 days prior to step 2 randomization)
- STEP 2: RANDOMIZATION: Platelets >= 75 x 10^3/uL and participants must not have
received platelet transfusion within 72 hours prior to this lab being drawn (within
7 days prior to step 2 randomization)
- STEP 2: RANDOMIZATION: Total bilirubin =< 2 x institutional ULN (within 7 days prior
to step 2 randomization)
- Unless due to Gilbert's disease or lymphomatous involvement of liver
- STEP 2: RANDOMIZATION: AST and ALT =< 3 x institutional ULN (within 7 days prior to
step 2 randomization)
- STEP 2: RANDOMIZATION: Creatinine clearance >= 40 mL/min, as estimated by the
Cockcroft and Gault formula. The creatinine value used in the calculation must have
been obtained within 7 days prior to step 2 randomization. Estimated creatinine
clearance is based on actual body weight (within 7 days prior to step 2
randomization)
- STEP 2: RANDOMIZATION: Participants with peripheral neuropathy must have < grade 2
- STEP 2: RANDOMIZATION: Participants with current symptoms of cardiac disease must
have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification. To be eligible for this trial, participants
must be class 2B or better
- STEP 2: RANDOMIZATION: Participants with history of hepatitis B viral infection must
have undetectable viral load within 14 days prior to step 2 randomization and on
suppressive therapy
- STEP 2: RANDOMIZATION: Participants with history of hepatitis C viral infection must
have undetectable viral load within 14 days prior to step 2 randomization
- STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus
(HIV)-infection must be continuing to receive anti-retroviral therapy and have an
undetectable viral load test within 14 days prior to step 2 randomization
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have documented
disease progression while on Arm 4 (observation) on this protocol. The follow-up
tumor assessment form documenting disease progression must be submitted to SWOG
prior to step 3 crossover registration
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must be registered within
28 days of the date of progression
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have imaging that
clearly demonstrates progression compared to day +30 PET-CT scan
- Note: These scans should be performed as standard of care and only performed
between scheduled response assessments required for study if symptoms arise
that are concerning for progression
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have Zubrod PS of 0,
1, or 2
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): ANC >= 1.0 x 10^3/uL and participants
must not have received myeloid growth factor within 72 hours prior to this lab being
drawn (within 14 days prior to step 3 crossover registration)
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Platelets >= 75 x 10^3/uL and
participants must not have received platelet transfusion within 72 hours prior to
this lab being drawn (within 14 days prior to step 3 crossover registration)
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Total bilirubin =< 2 x institutional
ULN (within 14 days prior to step 3 crossover registration)
- Unless due to Gilbert's disease or lymphomatous involvement of liver
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): AST and ALT =< 3 x institutional ULN
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Creatinine clearance >= 40 mL/min, as
estimated by the Cockcroft and Gault formula. The creatinine value used in the
calculation must have been obtained within days prior to step 3 crossover
registration. Estimated creatinine clearance is based on actual body weight (within
14 days prior to step 3 crossover registration)
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with peripheral neuropathy
must have < grade 2
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with current symptoms of
cardiac disease must have a clinical risk assessment of cardiac function using the
New York Heart Association Functional Classification. To be eligible for this trial,
participants must be class 2B or better
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis
B viral infection must have undetectable viral load within 14 days prior to step 3
crossover registration and on suppressive therapy
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis
C viral infection must have undetectable viral load within 14 days prior to step 3
crossover registration
- STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with known human
immunodefici
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner University Medical Center - Tucson
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
UACC-IIT@uacc.arizona.edu
Investigator:
Last name:
Muhammad Husnain
Email:
Principal Investigator
Facility:
Name:
University of Arizona Cancer Center-North Campus
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
UACC-IIT@uacc.arizona.edu
Investigator:
Last name:
Muhammad Husnain
Email:
Principal Investigator
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
501-686-8274
Investigator:
Last name:
Cesar Gentille
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Elizabeth A. Brem
Email:
Principal Investigator
Facility:
Name:
UCSF Medical Center-Parnassus
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-3222
Investigator:
Last name:
Madhav R. Seshadri
Email:
Principal Investigator
Facility:
Name:
University of Florida Health Science Center - Gainesville
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
352-273-8010
Email:
cancer-center@ufl.edu
Investigator:
Last name:
Erin Dean
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-778-1868
Investigator:
Last name:
Jason T. Romancik
Email:
Principal Investigator
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-851-7115
Investigator:
Last name:
Jason T. Romancik
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Boise
Address:
City:
Boise
Zip:
83712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Fruitland
Address:
City:
Fruitland
Zip:
83619
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Meridian
Address:
City:
Meridian
Zip:
83642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Nampa
Address:
City:
Nampa
Zip:
83686
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Twin Falls
Address:
City:
Twin Falls
Zip:
83301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
University of Illinois
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-355-3046
Investigator:
Last name:
Carlos Galvez
Email:
Principal Investigator
Facility:
Name:
University of Chicago Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Justin P. Kline
Email:
Principal Investigator
Facility:
Name:
Loyola University Medical Center
Address:
City:
Maywood
Zip:
60153
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
708-226-4357
Investigator:
Last name:
Patrick J. Stiff
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Marc S. Hoffmann
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center-Overland Park
Address:
City:
Overland Park
Zip:
66210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Marc S. Hoffmann
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Westwood Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Marc S. Hoffmann
Email:
Principal Investigator
Facility:
Name:
Bronson Battle Creek
Address:
City:
Battle Creek
Zip:
49017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Wayne State University/Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
313-576-9790
Email:
ctoadmin@karmanos.org
Investigator:
Last name:
Joseph P. Uberti
Email:
Principal Investigator
Facility:
Name:
Weisberg Cancer Treatment Center
Address:
City:
Farmington Hills
Zip:
48334
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
313-576-9790
Email:
ctoadmin@karmanos.org
Investigator:
Last name:
Joseph P. Uberti
Email:
Principal Investigator
Facility:
Name:
Spectrum Health at Butterworth Campus
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Trinity Health Grand Rapids Hospital
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Bronson Methodist Hospital
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
West Michigan Cancer Center
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Ascension Borgess Cancer Center
Address:
City:
Kalamazoo
Zip:
49009
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Trinity Health Muskegon Hospital
Address:
City:
Muskegon
Zip:
49444
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Cancer and Hematology Centers of Western Michigan - Norton Shores
Address:
City:
Norton Shores
Zip:
49444
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
connie.szczepanek@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Corewell Health Reed City Hospital
Address:
City:
Reed City
Zip:
49677
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Address:
City:
Saint Joseph
Zip:
49085
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Ascension Providence Hospitals - Southfield
Address:
City:
Southfield
Zip:
48075
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
248-849-5332
Email:
karen.fife@ascension.org
Investigator:
Last name:
Adam M. Forman
Email:
Principal Investigator
Facility:
Name:
Munson Medical Center
Address:
City:
Traverse City
Zip:
49684
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
University of Michigan Health - West
Address:
City:
Wyoming
Zip:
49519
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
505-925-0348
Email:
HSC-ClinicalTrialInfo@salud.unm.edu
Investigator:
Last name:
Shashank Cingam
Email:
Principal Investigator
Facility:
Name:
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-342-5162
Email:
cancerclinicaltrials@cumc.columbia.edu
Investigator:
Last name:
Hua-Jay J. Cherng
Email:
Principal Investigator
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-275-5830
Investigator:
Last name:
Paul M. Barr
Email:
Principal Investigator
Facility:
Name:
Wilmot Cancer Institute at Webster
Address:
City:
Webster
Zip:
14580
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
WCICTOresearch@urmc.rochester.edu
Investigator:
Last name:
Paul M. Barr
Email:
Principal Investigator
Facility:
Name:
Carolinas Medical Center/Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-9376
Investigator:
Last name:
Nilanjan Ghosh
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-275-3853
Investigator:
Last name:
Matthew S. McKinney
Email:
Principal Investigator
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
336-713-6771
Investigator:
Last name:
Rakhee Vaidya
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Changchun Deng
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Sami Ibrahimi
Email:
Principal Investigator
Facility:
Name:
Providence Newberg Medical Center
Address:
City:
Newberg
Zip:
97132
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Willamette Falls Medical Center
Address:
City:
Oregon City
Zip:
97045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Andy I. Chen
Email:
Principal Investigator
Facility:
Name:
Geisinger Medical Center
Address:
City:
Danville
Zip:
17822
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-271-5251
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Joseph P. Lynch
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania/Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Suspended
Facility:
Name:
Geisinger Wyoming Valley/Henry Cancer Center
Address:
City:
Wilkes-Barre
Zip:
18711
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-271-5251
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Joseph P. Lynch
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Spartanburg
Address:
City:
Boiling Springs
Zip:
29316
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
843-792-9321
Email:
hcc-clinical-trials@musc.edu
Investigator:
Last name:
Brian T. Hess
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Easley
Address:
City:
Easley
Zip:
29640
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-522-2066
Email:
Kim.Williams3@prismahealth.org
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Butternut
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Faris
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Eastside
Address:
City:
Greenville
Zip:
29615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Greer
Address:
City:
Greer
Zip:
29650
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Prisma Health Cancer Institute - Seneca
Address:
City:
Seneca
Zip:
29672
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Suzanne R. Fanning
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Memphis
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Brion V. Randolph
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CTOclinops@vcu.edu
Investigator:
Last name:
Sneha Purvey
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Priyanka Pophali
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-805-3666
Investigator:
Last name:
Mehdi Hamadani
Email:
Principal Investigator
Facility:
Name:
Froedtert and MCW Moorland Reserve Health Center
Address:
City:
New Berlin
Zip:
53151
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-805-0505
Investigator:
Last name:
Mehdi Hamadani
Email:
Principal Investigator
Start date:
June 12, 2023
Completion date:
December 4, 2029
Lead sponsor:
Agency:
SWOG Cancer Research Network
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
SWOG Cancer Research Network
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633615
