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CAR T-cell Therapy
ALLO-647 + CAR T Cell Therapy for Large B-Cell Lymphoma (EXPAND Trial)
Phase 2
Recruiting
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 60 months
Awards & highlights
EXPAND Trial 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.Check my eligibility
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.See study design
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.
EXPAND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by IRC in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma)
Secondary outcome measures
To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by IRC in subjects with R/R LBCL
To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms
To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number
+11 moreEXPAND 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
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Allogene TherapeuticsLead Sponsor
5 Previous Clinical Trials
622 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored in this research project?
"Affirmative. Clinicaltrials.gov provides evidence that this study is presently recruiting for 70 participants at a single location. The original post was published on March 31st 2023 and the listing has been modified as recently as April 11th 2023."
Answered by AI
Has the application of Lymphodepletion with fludarabine and cyclophosphamide been endorsed by the FDA?
"Taking into account the data collected so far, our team at Power has rated Lymphodepletion with fludarabine and cyclophosphamide a 2 for safety. This is due to this being a Phase 2 trial meaning there are studies that support its safety but none backing its efficacy."
Answered by AI
Are there any vacancies for patients to participate in this clinical trial?
"Per the data hosted on clinicaltrials.gov, this medical research is actively recruiting patients. The trial was originally posted on March 31st 2023 and has been subsequently updated as recently as April 11th of the same year."
Answered by AI
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