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A trial to find out if odronextamab combined with lenalidomide is safe and works better than rituximab combined with lenalidomide in adult participants with follicular lymphoma and marginal zone lymphoma
EU CTIS ID: 2022-503092-28-00
What this study is testing
Part 1 (Safety Run-In) Assess the safety, tolerability, and dose-limiting toxicities (DLTs) of odronextamab in combination with lenalidomide in participants with relapsed/refractory (R/R) indolent lymphoma (FL and MZL). Part 2 (Randomized Phase) To compare the efficacy of odronextamab in combination with lenalidomide versus rituximab in combination with lenalidomide (R2) in participants with R/R FL and subsequently in participants with indolent lymphoma (combined R/R FL and marginal zone lymphoma (MZL)) as measured by progression-free survival (PFS) per independent central review.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
- Have refractory disease or relapsed after at least one prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment as described in the protocol.
- Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic and organ function, as described in the protocol.
- All study participants must: a. Have an understanding that lenalidomide could have a potential teratogenic risk. b. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. c. Agree not to share study medication with another person. d. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
You likely can't join if
- Primary central nervous system (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS Non-Hodgkin lymphoma (NHL), as described in the protocol.
- Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
- History of or current relevant CNS pathology, as described in the protocol.
- A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
- Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
- Allergy/hypersensitivity to study drugs or excipients, as described in the protocol.
See the full eligibility criteria
- Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
- Have refractory disease or relapsed after at least one prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment as described in the protocol.
- Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic and organ function, as described in the protocol.
- All study participants must: a. Have an understanding that lenalidomide could have a potential teratogenic risk. b. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. c. Agree not to share study medication with another person. d. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
- Note: Other protocol-defined Inclusion criteria apply
- Primary central nervous system (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS Non-Hodgkin lymphoma (NHL), as described in the protocol.
- Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
- History of or current relevant CNS pathology, as described in the protocol.
- A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
- Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
- Allergy/hypersensitivity to study drugs or excipients, as described in the protocol.
- Active infection as defined in the protocol.
- Note: Other protocol-defined Exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Turkey
- Brazil
- United States
- Korea, Republic of
- Taiwan
- United Kingdom
- Thailand
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Turkey; Brazil; United States; Korea, Republic of; Taiwan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.