Trial NCT06091254
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
- Phase
- Phase 3
- Sponsor
- Regeneron Pharmaceuticals
- Conditions
- Follicular Lymphoma (FL)
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
1. Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2Performance status
5. Adequate bone marrow function and hepatic function, as described in the protocol
Key Exclusion Criteria:
1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphomaBrain metastases
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
Restrictions found (2)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-2
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County