Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
Allogene Therapeutics
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Start date
2024-06-18
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Number of sites
86
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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 for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
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Acronym
ALPHA3
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Short title
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
clinicaltrials.gov
Official title
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2032-12-01
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First posted
2024-07-15
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Registry last updated
2026-10-30
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Primary completion date
2027-12-01
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Start date
2024-06-18
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
5
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Randomisation ratio
1:1
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Number of sites
86
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Allogene Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06500273
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ClinicalTrials.gov ID
NCT06500273
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Event-free survival per independent review committee assessment

    Timeframe: Up to 60 months

  1. Progression-free survival per independent review committee assessment

    Timeframe: Up to 60 months

  2. Overall survival

    Timeframe: Up to 60 months

  3. Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647

    Timeframe: Up to 60 months

    Adverse events, treatment emergent adverse events, serious adverse events, and adverse events of special interest evaluated by the investigator based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CRS and ICANS will be graded using ASTCT.

  4. Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647

    Timeframe: Up to 60 months

    Change from baseline value and NCI toxicity grading of laboratory values outside of normal ranges using CTCAE version 5.0.

  5. Minimal residual disease clearance

    Timeframe: Up to 60 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. 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.
  2. 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.
  3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
  4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
  5. Adult participants ≥18 years of age.
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Key Exclusion Criteria:

  1. 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.
  2. Prior treatment with anti-CD19 targeted therapies.
  3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
  4. Active and clinically significant autoimmune disease.
  5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
  6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Sources for eligibility
clinicaltrials.gov

  • Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting
  • Genesis Cancer and Blood InstituteHot Springs, United StatesRecruiting
  • Alta Bates Summit Medical CenterBerkeley, United StatesRecruiting
  • City of HopeDuarte, United StatesRecruiting
  • Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting
  • University of California, Los AngelesLos Angeles, United StatesRecruiting
  • University of California, Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting
  • University of California, San DiegoSan Diego, United StatesRecruiting
  • University of California, San FranciscoSan Francisco, United StatesRecruiting
  • Rocky Mountain Cancer CentersLone Tree, United StatesRecruiting
  • Medical Oncology Hematology ConsultantsNewark, United StatesRecruiting
  • MedStar Georgetown University HospitalWashington D.C., United StatesRecruiting
  • Miami Cancer Institute at Baptist Health, Inc.Miami, United StatesRecruiting
  • Advent Health Cancer InstituteOrlando, United StatesRecruiting
  • Orlando Health Cancer InstituteOrlando, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Winship Cancer Institute - Emory UniversityAtlanta, United StatesActive, not recruiting
  • Augusta University Georgia Cancer CenterAugusta, United StatesRecruiting
  • Northwestern University - Feinberg School of MedicineChicago, United StatesRecruiting
  • Rush University Medical CenterChicago, United StatesRecruiting
  • Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesRecruiting
  • IU Simon Comprehensive Cancer CenterIndianapolis, United StatesRecruiting
  • Indiana Blood and Marrow TransplantationIndianapolis, United StatesRecruiting
  • The University of Kansas HospitalKansas City, United StatesActive, not recruiting
  • University of Kentucky Medical CenterLexington, United StatesRecruiting

And 61 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Collaborators (2)

Lead sponsors (1)

Conditions (2)

Targets (2)