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CAR T-cell Therapy
ALLO-647 + CAR T Cell Therapy for Large B-Cell Lymphoma (EXPAND Trial)
Phase 2
Waitlist Available
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if adding a new drug to an existing lymphoma treatment can improve safety and effectiveness.
Who is the study for?
This trial is for adults with large B-cell lymphoma that has come back or hasn't responded to treatment. Participants must have had at least two prior chemotherapy treatments, be in good physical condition (ECOG status 0 or 1), and not have immune reactions against donor cells. They can't join if they've had a bone marrow transplant in the last six months or cancer affecting their central nervous system.
What is being tested?
The EXPAND study is testing whether adding ALLO-647 to the usual drugs fludarabine and cyclophosphamide helps improve outcomes when given before CAR T cell therapy (ALLO-501A) in patients whose large B-cell lymphoma has relapsed or is resistant to treatment.
What are the potential side effects?
Possible side effects include those related to CAR T cell therapy like fever, difficulty breathing, rapid heartbeat, low blood pressure, confusion; and from chemotherapy such as nausea, hair loss, mouth sores, fatigue, increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lymphodepletion with fludarabine and cyclophosphamideExperimental Treatment3 Interventions
ALLO-501A CAR T cells infused following lymphodepletion
Group II: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamideExperimental Treatment4 Interventions
ALLO-501A CAR T cells infused following lymphodepletion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Find a Location
Who is running the clinical trial?
Allogene TherapeuticsLead Sponsor
6 Previous Clinical Trials
742 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition did not improve after 2 chemotherapy treatments.My blood, kidney, and liver tests are within normal ranges.I had a stem cell transplant within the last 6 months.My last relapse was confirmed as a severe type of large B-cell lymphoma.My cancer has spread to my brain or spinal cord.I am fully active or can carry out light work.My bone marrow is less active than normal for my age.
Research Study Groups:
This trial has the following groups:- Group 1: Lymphodepletion with fludarabine and cyclophosphamide
- Group 2: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.