This study has been transitioned to CTIS with ID 2023-505628-67-00 check the CTIS register for the current data. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult…
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression-Free Survival (PFS)
Secondary outcome
Percentage of Participants Achieving Complete Response (CR)
Percentage of Participants Achieving Best Overall Response (BOR)
Overall Survival (OS)
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
Background summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most
common type of cancer of lymphocytes. Unfortunately, this disease is incurable
with conventional treatment and the disease recurs in almost all patients.
Study objective
This study has been transitioned to CTIS with ID 2023-505628-67-00 check the CTIS register for the current data.
This study will assess how safe and effective epcoritamab is in combination
with lenalidomide and rituximab (R2) in treating adult participants with
relapsed or refractory (R/R) FL. Adverse events and change in disease condition
will be assessed.
Study design
Open-label randomized Phase 3 study
Intervention
Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up
to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone
or in combination with subcutaneous injections of epcoritamab for up to 12
cycles (each cycle is 28 days).
Three arm groups:
Participants will receive epcoritamab Dose A in combination with lenalidomide
and rituximab (R2) for 12 cycles (each cycle is 28 days).
Participants will receive epcoritamab Dose B in combination with lenalidomide
and rituximab (R2) for 12 cycles (each cycle is 28 days).
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each
cycle is 28 days)
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care. Participants will attend regular visits during the
study at a hospital or clinic. The effect of the treatment will be checked by
medical assessments, blood tests, checking for side effects and completing
questionnaires
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
1. Adult individuals, at least 18 years old.
2. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance
status score 0 - 2.
3. Subject has:
• Fluorodeoxyglucose-positron emission tomography (FDG PET) scan
demonstrating positive lesion
compatible with computed tomography (CT) or magnetic resonance
image (MRI)-defined anatomical
tumor sites AND
• >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable
extra-nodal lesion (long axis > 1.0 cm) on CT scan or
magnetic resonance image (MRI)
4. Subject must have histologically confirmed classic FL (previously Grade 1 to
3a FL) according to the 5th edition of World Health
Organization (WHO) of Haematolymphoid Tumours with no evidence of histologic
transformation to an aggressive lymphoma at most recent representative tumor
biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
5. Subject must have R/R disease after receiving treatment with at least one
prior antilymphoma regimen that contained an antiCD20 monoclonal antibody in
combination with chemotherapy. (Subject who received only prior anti-CD20
monoclonal antibody monotherapy and/or radiation therapy is not eligible.)
6. Subject must be eligible to receive R2 per investigator determination
Exclusion criteria
1. Subject must not have documented refractoriness to lenalidomide, with
refractoriness defined as:
o Best response to lenalidomide of stable disease or progressive
disease, or
o Progressive disease within 6 months of completion of lenalidomide
therapy
2. Subjects must not have had lenalidomide exposure within 12 months prior to
randomization
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505628-67-00 |
| EudraCT | EUCTR2021-000169-34-NL |
| CCMO | NL81686.028.22 |