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CAR T-cell Therapy

Arm A: Liso-cel Monotherapy for Chronic B-Cell Leukemia

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from the last participant randomized

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My cancer can be measured and tracked over time.

Select...

I can do my daily activities without any problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from the last participant randomized

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) per independent review committee (IRC) assessment

Secondary outcome measures

CRR per investigators' assessment

Complete Response Rate (CRR) per IRC assessment

Complete response with incomplete bone marrow recovery (CRi)

+20 more

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

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,236 Total Patients Enrolled

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor

14 Previous Clinical Trials

1,727 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,981 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different venues is this medical investigation currently accessible?

"This trial is currently underway at a total of 43 locations. Notable sites include Local Institution - 0037 in Paris, Local Institution - 0091 in Milan, and Stony Brook University located in Stony Brook."

Answered by AI

What is the level of safety associated with Arm A, specifically in regards to Liso-cel Monotherapy for patients?

"Based on its Phase 3 status, Arm A: Liso-cel Monotherapy is assigned a safety rating of 3 by our team at Power. This signifies that there exists evidence supporting both the effectiveness and safety of this treatment option through multiple rounds of data analysis."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"As per the information available on clinicaltrials.gov, this trial is not currently seeking participants. It was initially posted on January 16th, 2024 and last updated on January 9th, 2024. However, it's worth noting that there are presently over 2775 other ongoing studies actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

2024. "A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205290.