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CAR T-cell Therapy

Arm A: Liso-cel Monotherapy for Follicular Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have measurable disease, which will be evaluated before each participant takes part in the study
Must have an ECOG performance score of 0 or 1, indicating the ability to carry out normal daily activities without any problems
Must not have
Having certain brain conditions
Bleeding disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from the last participant randomized
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is comparing the effectiveness and safety of liso-cel to other treatment options in adults with a type of blood cancer called CLL or SLL. The participants in this trial have not responded to

Who is the study for?
This trial is for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that didn't respond to BTKi and BCL2i treatments. Participants should have measurable disease, be able to perform daily activities (ECOG score 0-1), and not have heart issues, uncontrolled infections, brain cancer, bleeding disorders, or certain past treatments.
What is being tested?
The study compares the effectiveness of Lisocabtagene Maraleucel (liso-cel) against other options like Idelalisib + Rituximab or Bendamustine + Rituximab in patients whose leukemia/lymphoma has resisted previous targeted therapies.
What are the potential side effects?
Potential side effects include immune system reactions, infusion-related symptoms, low blood cell counts leading to increased infection risk or bleeding problems. There may also be fatigue and adverse reactions specific to each drug being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured and tracked over time.
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I can do my daily activities without any problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a specific brain condition.
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I have a bleeding disorder.
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I have active cancer in my brain.
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I have an infection that is not currently under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from the last participant randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from the last participant randomized for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean changes from baseline in the following key HRQoL domains: Cognitive functioning
Mean changes from baseline in the following key HRQoL domains: Fatigue
Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Liso-cel MonotherapyExperimental Treatment3 Interventions
Group II: Arm B: Investigator's ChoiceActive Control3 Interventions
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?

Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,659 Total Patients Enrolled
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor
15 Previous Clinical Trials
2,167 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,567 Previous Clinical Trials
3,384,262 Total Patients Enrolled
~0 spots leftby Oct 2031
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