Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT04416984 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04416984 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04416984?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ALLO-647 (BIOLOGICAL), ALLO-501A (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04416984?
This trial is sponsored by Allogene Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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