BridgeMD
New treatment option for Relapsed/Refractory Follicular Lymphoma
Official title 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
ClinicalTrials.gov ID: NCT06149286
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, given as an once-daily, being studied as a potential treatment for relapsed/refractory follicular lymphoma.
Also referred to as REGN1979, Ordspono.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory").
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or...
- Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] imaging, as...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic and organ function, as described in the protocol.
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 NHL, as...
- 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...
- 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...
- Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant...
- 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.
- Must have refractory disease or relapsed after at least 1 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...
- 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:
- Have an understanding that lenalidomide could have a potential teratogenic risk.
- Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
- Agree not to share study medication with another person.
- Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide. Key
- Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS 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...
- 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 Inclusion/Exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Plantation, Florida, United States
- Indianapolis, Indiana, United States
- Hattiesburg, Mississippi, United States
- Lebanon, New Hampshire, United States
- Stony Brook, New York, United States
- Westbury, New York, United States
- Waukesha, Wisconsin, United States
- Liverpool, New South Wales, Australia
- Waratah, New South Wales, Australia
- Benowa, Queensland, Australia
- Hobart, Tasmania, Australia
- East Melbourne, Victoria, Australia
- Linz, Osterreich, Austria
- Linz, Upper Austria, Austria
- Vienna, Austria
- Wels, Austria
- Yvoir, Namur, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Roeselare, West-Vlaanderen, Belgium
+ 123 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Plantation, Florida, United States; Indianapolis, Indiana, United States; Hattiesburg, Mississippi, United States; Lebanon, New Hampshire, United States; Stony Brook, New York, United States and 137 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 ClinicalTrials.gov; the study team decides eligibility.