Trial Title:
Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma
NCT ID:
NCT06112847
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lenalidomide
Antibodies, Bispecific
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow biopsy
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT or PET/CT
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Treatment (lenalidomide and epcoritamab)
Intervention type:
Biological
Intervention name:
Epcoritamab
Description:
Given SC
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
Anti-CD20/CD3 Bispecific Antibody GEN3013
Other name:
DuoBody-CD3xCD20
Other name:
Epcoritamab-bysp
Other name:
Epkinly
Other name:
GEN 3013
Other name:
GEN-3013
Other name:
GEN3013
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Given PO
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
CC-5013
Other name:
CC5013
Other name:
CDC 501
Other name:
Revlimid
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (lenalidomide and epcoritamab)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
This phase II trial tests how well lenalidomide and epcoritamab works in treating
patients with follicular lymphoma that has not been previously treated. Although
follicular lymphoma is incurable, prognosis has improved for both early and advanced
stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or
suppress the immune system in different ways and stop cancer cells from growing and by
preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is
a bispecific monoclonal antibody that binds to two different antigens (the part of the
target that the antibody attaches to), at the same time. This dual action allows
bispecific antibodies to improve target specificity by binding two antigens on the same
cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and
epcoritamab, when given together, may be more effective in treating patients with
follicular lymphoma than if they were given alone.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess efficacy (complete response [CR] rate) of epcoritamab and lenalidomide
(E-Len) in patients with de novo follicular lymphoma (FL).
SECONDARY OBJECTIVES:
I. To further assess efficacy of the combination (objective response rate [ORR],
progression free survival [PFS], duration of response).
II. To characterize the adverse event profile of the combination.
EXPLORATORY OBJECTIVES:
I. To characterize the T-cell population balance in patients treated with E-Len.
II. To evaluate the predictive role of genetic mutations on durability of response to
E-Len (including m7 Follicular Lymphoma International Prognostic Index [FLIPI] score).
III. To evaluate minimal residual disease (MRD) dynamics on treatment.
OUTLINE:
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 of each cycle and
epcoritamab subcutaneously (SC) on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of
each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles in the absence
of disease progression or unacceptable toxicity. Patients may be re-treated with study
treatment at any point during the follow-up period as long as they did not progress
during treatment or stop due to unacceptable toxicity. Patients also undergo computed
tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging
(MRI) as well as bone marrow biopsy throughout the trial. Patients undergo blood sample
collection on trial and during follow-up.
After completion of study treatment, patients are followed for safety on days 7, 30, and
60, for active response every 6 months for up to 2 years, and then for survival every 6
months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Histologically confirmed previously untreated FL grade 1-3a, requiring therapy per
Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- Radiologically measurable lymphadenopathy (> 1.5 cm) or extranodal involvement
(including spleen, bone marrow or other extranodal site)
- Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm^3 With
bone marrow involvement: ANC ≥ 500/mm^3
- NOTE: Growth factor is not permitted within 14 days of ANC assessment unless
cytopenia is secondary to disease involvement
- Without bone marrow involvement: Platelets ≥ 50,000/mm^3 With bone marrow
involvement: Platelets ≥ 25,000/mm^3
- NOTE: Platelet transfusions are not permitted within 14 days of platelet
assessment unless cytopenia is secondary to disease involvement.
- Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease)
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault
formula or creatinine level < 1.5 mg/dL
- If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin
(PT) ≤ 1.5 x ULN
- If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5
x ULN
- Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum
pregnancy test will be required
- Agreement by females and males of childbearing potential* to use an effective method
of birth control (i.e., failure rate of < 1% per year) or abstain from heterosexual
activity for the course of the study treatment period through at least 30 days after
the last dose of lenalidomide, and 2 months after the last dose of epcoritamab, or 4
months after the last dose of tocilizumab (if applicable) whichever is longer
- Childbearing potential defined as not being surgically sterilized (men and
women) or have not been free from .menses for > 1 year (women only)
- All study participants must be registered into the mandatory Revlimid Risk
Evaluation and Mitigation Strategy (REMS)® program and be willing and able
to comply with the requirements of the REMS program (including use of
aspirin [ASA]/Food and Drug Administration [FDA] approved blood thinner)
- Females of reproductive potential must adhere to the scheduled pregnancy
testing as required in the Revlimid REMS program
Exclusion Criteria:
- Prior therapeutic intervention with any anti-cancer agents; localized radiotherapy ≤
20 Gy total dose is permissible if occurred ≥ 4 weeks prior to first dose of study
medication.
- Participants must have at least one non-irradiated target lesion
- Concurrent enrollment in another therapeutic investigational study
- Vaccinated with live vaccines within 4 weeks of the first dose of study drug
- Current evidence of central nervous system involvement by the lymphoma
- Grade 3b or transformed FL
- History of prior malignancy except:
- Malignancy treated with curative intent and no known active disease present for
≥ 2 years prior to initiation of therapy on current study
- Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in
situ) without evidence of disease
- Asymptomatic prostate cancer managed with "watch and wait" strategy or hormonal
therapy
- Uncontrolled active systemic infection
- Absolute lymphocyte count > 5,000/uL
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with
past HBV infection (defined as negative hepatitis B virus surface protein antigen
[HbsAg] and positive hepatitis B core antibody [HbcAb]) are eligible if HBV
deoxyribonucleic acid (DNA) is undetectable. Patients who are positive for HCV
antibody are eligible if polymerase chain reaction (PCR) is negative for HCV
ribonucleic acid (RNA). Testing to be done only in patients suspected of having
infections or exposures
- Known active human immunodeficiency virus (HIV) infection. Subjects who have an
undetectable or unquantifiable HIV viral load with CD4 > 200 and are on highly
active antiretroviral therapy (HAART) medication are allowed. Testing to be done
only in patients suspected of having infections or exposures
- Currently active, clinically significant cardiovascular disease, such as
uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the
New York Heart Association Functional Classification; or a history of myocardial
infarction, unstable angina, or acute coronary syndrome within 6 months of screening
- Females only: Pregnant or breastfeeding or intending to become pregnant during the
study or within 6 months after the final dose of all study drugs
- Women of childbearing potential must have a negative serum pregnancy test
result within 14 days prior to initiation of study drug
- Any other condition that would, in the Investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns with clinical
study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to
comply with all study procedures (including compliance issues related to
feasibility/logistics)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swetha Kambhampati
Phone:
626-256-4673
Phone ext:
82405
Email:
skambhampati@coh.org
Investigator:
Last name:
Swetha Kambhampati
Email:
Principal Investigator
Facility:
Name:
City of Hope at Irvine Lennar
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swetha Kambhampati
Phone:
626-256-4673
Phone ext:
82405
Email:
skambhampati@coh.org
Investigator:
Last name:
Swetha Kambhampati
Email:
Principal Investigator
Start date:
January 24, 2024
Completion date:
October 14, 2025
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112847
