Status:
RECRUITING
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Lead Sponsor:
Allogene Therapeutics
Collaborating Sponsors:
Foresight Diagnostics, Inc.
Conditions:
Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable f...
Eligibility Criteria
Inclusion
- Key
- LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
- Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
- Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
- Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
- Adult participants ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
- Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.
- Key
Exclusion
- LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
- Prior treatment with anti-CD19 targeted therapies.
- Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
- Active and clinically significant autoimmune disease.
- Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
- History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Key Trial Info
Start Date :
June 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2031
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06500273
Start Date
June 18 2024
End Date
August 24 2031
Last Update
December 22 2025
Active Locations (59)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States, 71913
3
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
4
City of Hope
Duarte, California, United States, 91010