Trial Title:
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
NCT ID:
NCT06317649
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Gilteritinib
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:
Drug
Intervention name:
Azacitidine
Description:
Given IV or SC
Arm group label:
Regimen 1 (azacitidine, venetoclax)
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Other name:
5 AZC
Other name:
5-AC
Other name:
5-Azacitidine
Other name:
5-Azacytidine
Other name:
5-AZC
Other name:
Azacytidine
Other name:
Azacytidine, 5-
Other name:
Ladakamycin
Other name:
Mylosar
Other name:
U-18496
Other name:
Vidaza
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Regimen 1 (azacitidine, venetoclax)
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow biopsy and aspiration
Arm group label:
Regimen 1 (azacitidine, venetoclax)
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow biopsy and aspiration
Arm group label:
Regimen 1 (azacitidine, venetoclax)
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Drug
Intervention name:
Gilteritinib
Description:
Given PO
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Other name:
ASP 2215
Other name:
ASP-2215
Other name:
ASP2215
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Given PO
Arm group label:
Regimen 1 (azacitidine, venetoclax)
Arm group label:
Regimen 2 (azacitidine, venetoclax, gilteritinib)
Arm group label:
Regimen 3 (azacitidine, venetoclax, gilteritinib)
Other name:
ABT 199
Other name:
ABT-0199
Other name:
ABT-199
Other name:
ABT199
Other name:
GDC 0199
Other name:
GDC-0199
Other name:
GDC0199
Other name:
RG7601
Other name:
Venclexta
Other name:
Venclyxto
Summary:
This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and
venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in
treating older and unfit patients with acute myeloid leukemia and FLT3 mutations.
Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer
suppressor genes, which are genes that help control cell growth. Venetoclax is in a class
of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of
cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib
is in a class of medications called kinase inhibitors. It works by blocking the action of
a certain naturally occurring substance that may be needed to help cancer cells multiply.
This study may help doctors find out if these different approaches are better than the
usual approaches. To decide if they are better, the study doctors are looking to see if
the study drugs lead to a higher percentage of patients achieving a deeper remission
compared to the usual approach.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare the achievement rate of measured residual disease negative (MRDneg)
complete remission (CR) of either triplet regimen to azacitidine and venetoclax alone
within 4 cycles of therapy.
SECONDARY OBJECTIVES:
I. To compare the achievement rate of MRDneg CR/complete remission with incomplete count
recovery (CRi)/complete remission with partial hematologic recovery (CRh) of either
triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy.
II. To determine the safety and tolerability of the combination of gilteritinib,
azacitidine, and venetoclax, if both of the triplet regimens show superiority to the
azacitidine plus venetoclax regimen.
III. To determine the optimal sequence and duration of gilteritinib, when added to
azacitidine and venetoclax if both of the triplet regimens show superiority to the
azacitidine plus venetoclax regimen.
IV. To estimate the rates of complete remission (CR), complete remission with incomplete
count recovery (CRi), and complete remission with partial hematologic recovery (CRh),
morphologic leukemia-free state (MLFS), event-free survival (EFS), and overall survival
(OS) of the combination of gilteritinib, azacitidine, and venetoclax versus azacitidine
and venetoclax alone.
EXPLORATORY OBJECTIVES:
I. To establish the degree reduction in FLT3- internal tandem duplication (ITD) mutation
burden after 2 and 4 cycles of therapy using a highly sensitive next-generation
sequencing (NGS) MRD assay and compare the median reduction in the investigational
regimens among patients with CR/CRi/CRh to that of control regimen.
II. To determine if the degree of FLT3 ITD reduction is associated with the duration of
remission.
III. To monitor which mutations are present at the time of relapse. IV. To monitor which
co-mutations at presentation are associated with lack of response to these regimens.
V. To determine if the FLT3 AR /variant allele frequency (VAF) is associated with
response to the regimens.
OUTLINE: Patients are randomized to 1 of 3 regimens.
REGIMEN 1:
INDUCTION: Patients receive azacitidine intravenously (IV) or subcutaneously (SC) on days
1-7 of each cycle and venetoclax orally (PO) on days 1-28 of each cycle. Treatment
repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever
comes first, in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on
days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of
disease progression or unacceptable toxicity.
REGIMEN 2:
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and
gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2
cycles or until patient achieves remission, whichever comes first, in the absence of
disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days
1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2
years in the absence of disease progression or unacceptable toxicity.
REGIMEN 3:
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days
1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for
up to 2 cycles or until patient achieves remission, whichever comes first, in the absence
of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days
1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2
years in the absence of disease progression or unacceptable toxicity.
All patients undergo bone marrow biopsy and aspiration as well as blood sample collection
on the trial.
After completion of study treatment, patients are followed up every 3 months if patient
is < 2 years from first registration, and every 6 months if patient is 2-5 years from
first registration. All patients, including those who discontinue protocol therapy early,
are followed for response until progression, even if non-protocol therapy is initiated,
and for survival for 10 years from the date of randomization.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating
physician are better served by azanucleoside-based therapy rather than intensive,
cytarabine-based induction based on clinical status (i.e., performance status, age >
75 years), organ dysfunction, or disease biology
- Patient must have a morphologically confirmed diagnosis of AML according to the
World Health Organization (WHO) 2016 classification excluding acute promyelocytic
leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
- Patient must have no prior therapy for AML with the exception of hydroxyurea and
all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based
emergency therapy prior to the start of therapy on this trial are eligible
- Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
- Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening
and Reassessment Protocol (MSRP)
- Patient must be assigned to this protocol by the myeloMATCH MSRP
- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used.
- All patients of childbearing potential must have a blood test or urine study
within 14 days prior to registration to rule out pregnancy.
- A patient of childbearing potential is defined as anyone, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not
undergone a hysterectomy or bilateral oophorectomy; or 3) has not been
naturally postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months)
- Patient of childbearing potential and/or sexually active patients must not expect to
conceive or father children by using an accepted and effective method(s) of
contraception or by abstaining from sexual intercourse for the duration of their
participation in the study. Contraception measures must continue for 30 days after
the last dose of venetoclax for all patients and for 6 months after the last dose of
gilteritinib for patients of childbearing potential and for 4 months after the last
dose of gilteritinib for male patients with partners of childbearing potential.
Patient must not breastfeed during treatment and for 2 months after treatment ends
- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Patients with impaired decision-making capacity (IDMC)
who have a legally authorized representative (LAR) or caregiver and/or family member
available will also be considered eligible
- Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be
elevated due to disease involvement or Gilbert's syndrome)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase
[SGPT]) =< 3.0 x institutional ULN
- Either measured or estimated by Cockcroft-Gault equation
- Creatinine clearance of ≥ 30 mL/min/1.73m^2
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of registration/randomization
are eligible for this trial
- Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia
correction (QTcF).
NOTE: Since older patients are at risk for prolonged QTc and many will require supportive
care with agents that affect the QTc, an ECG is recommended if clinically indicated. If
the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of
EA02
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
- Patient must not have the medical necessity for ongoing treatment with a strong
CYP3A4 inducing drug
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- Patients must not have an active or uncontrolled infection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
203-785-5702
Email:
canceranswers@yale.edu
Investigator:
Last name:
Rory M. Shallis
Email:
Principal Investigator
Facility:
Name:
Veterans Affairs Connecticut Healthcare System-West Haven Campus
Address:
City:
West Haven
Zip:
06516
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
203-937-3421
Phone ext:
2832
Investigator:
Last name:
Alexander Pine
Email:
Principal Investigator
Facility:
Name:
Augusta University Medical Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
706-721-2388
Email:
ga_cares@augusta.edu
Investigator:
Last name:
Vamsi Kota
Email:
Principal Investigator
Facility:
Name:
Kootenai Health - Coeur d'Alene
Address:
City:
Coeur d'Alene
Zip:
83814
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Post Falls
Address:
City:
Post Falls
Zip:
83854
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Sandpoint
Address:
City:
Sandpoint
Zip:
83864
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Carle at The Riverfront
Address:
City:
Danville
Zip:
61832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@Carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Kishwaukee
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Effingham
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Glenview Outpatient Center
Address:
City:
Glenview
Zip:
60026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1102
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Grayslake Outpatient Center
Address:
City:
Grayslake
Zip:
60030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1102
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Lake Forest Hospital
Address:
City:
Lake Forest
Zip:
60045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
cancertrials@northwestern.edu
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Mattoon/Charleston
Address:
City:
Mattoon
Zip:
61938
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Orland Park
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
nctnprogram_rhlccc@northwestern.edu
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
Memorial Hospital East
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-747-9912
Email:
dschwab@wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-545-7929
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-444-7541
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Memorial Hospital
Address:
City:
Springfield
Zip:
62781
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-528-7541
Email:
pallante.beth@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Jessica K. Altman
Email:
Principal Investigator
Facility:
Name:
University of Kansas Clinical Research Center
Address:
City:
Fairway
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:
Jesus Gonzalez Lugo
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:
Jesus Gonzalez Lugo
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Indian Creek Campus
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Jesus Gonzalez Lugo
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:
Jesus Gonzalez Lugo
Email:
Principal Investigator
Facility:
Name:
The James Graham Brown Cancer Center at University of Louisville
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
502-562-3429
Investigator:
Last name:
Mohamed M. Hegazi
Email:
Principal Investigator
Facility:
Name:
UofL Health Medical Center Northeast
Address:
City:
Louisville
Zip:
40245
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
502-852-2755
Email:
ctoinfo@louisville.edu
Investigator:
Last name:
Mohamed M. Hegazi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Canton
Address:
City:
Canton
Zip:
48188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Address:
City:
Chelsea
Zip:
48118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesee Cancer and Blood Disease Treatment Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesee Hematology Oncology PC
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesys Hurley Cancer Institute
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Hurley Medical Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Mary Mercy Livonia Hospital
Address:
City:
Livonia
Zip:
48154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at West County Hospital
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center-South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Christian Hospital
Address:
City:
Saint Louis
Zip:
63136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Saint Peters Hospital
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Billings Clinic Cancer Center
Address:
City:
Billings
Zip:
59101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-996-2663
Email:
research@billingsclinic.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Bozeman Health Deaconess Hospital
Address:
City:
Bozeman
Zip:
59715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Benefis Sletten Cancer Institute
Address:
City:
Great Falls
Zip:
59405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Logan Health Medical Center
Address:
City:
Kalispell
Zip:
59901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Community Medical Center
Address:
City:
Missoula
Zip:
59804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Seven Hills
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Charleston
Address:
City:
Las Vegas
Zip:
89102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Fort Apache
Address:
City:
Las Vegas
Zip:
89148
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
505-925-0348
Email:
HSC-ClinicalTrialInfo@salud.unm.edu
Investigator:
Last name:
Charles Foucar
Email:
Principal Investigator
Facility:
Name:
State University of New York Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
315-464-5476
Investigator:
Last name:
Teresa C. Gentile
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:
Harry P. Erba
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:
Mohamad Khawandanah
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:
Alison K. Conlin
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:
Alison K. Conlin
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:
Alison K. Conlin
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:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Reading Hospital
Address:
City:
West Reading
Zip:
19611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
610-988-9323
Investigator:
Last name:
Terrence P. Cescon
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:
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:
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:
Keri R. Maher
Email:
Principal Investigator
Facility:
Name:
Centro Comprensivo de Cancer de UPR
Address:
City:
San Juan
Zip:
00927
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
ecog.rss@jimmy.harvard.edu
Investigator:
Last name:
Luis J. Santos Reyes
Email:
Principal Investigator
Facility:
Name:
San Juan City Hospital
Address:
City:
San Juan
Zip:
00936
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
787-763-1296
Investigator:
Last name:
Luis J. Santos Reyes
Email:
Principal Investigator
Start date:
September 27, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06317649