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NCT04416984 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)
A Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, sponsored by Allogene Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04416984 is a Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Allogene Therapeutics. The registered enrollment target is 160 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT04416984, a Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Allogene Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL ALLO-647
- GENETIC ALLO-501A
Study Locations (20)
California
- City of Hope - Duarte
- UCLA Medical Center - Los Angeles
- Stanford Cancer Institute - Palo Alto
Florida
- University of Miami - Miami
- Advent Health - Orlando
- Moffitt Cancer Center - Tampa
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital - Phoenix
Georgia
- Northside Hospital - Atlanta - Atlanta
- Augusta University - Augusta
Colorado
- Colorado Blood Cancer Institute - Denver
Connecticut
- Yale School of Medicine - New Haven
Illinois
- Loyola University Medical Center - Maywood
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04416984
The ClinicalTrials.gov registry entry for NCT04416984 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allogene Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04416984 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04416984 about?
NCT04416984 is a clinical study titled "Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)". This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the...
What is the current status of trial NCT04416984?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2020-05-21. Estimated completion is 2029-05.
What conditions does trial NCT04416984 study?
This clinical trial studies the following conditions: Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04416984?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ALLO-647 (BIOLOGICAL), ALLO-501A (GENETIC).
Who is sponsoring clinical trial NCT04416984?
This trial is sponsored by Allogene Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04416984 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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