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Leukemia, Lymphocytic, Chronic, B-CellPhase 3NCT06205290

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

A Phase 3 study testing Liso-cel, Idelalisib and Rituximab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 48 sites in 11 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
Liso-cel, Idelalisib and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
48 sitesin 11 countries
Study dates
16 Jan 2024to 13 Oct 2031
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have what doctors call measurable disease, which will be evaluated before each participant take part of the study.
  • Must have received both a BTKi and a BCL2i treatment, and their disease must have come back or not responded to treatment, or they must not have been able to tolerate the side-effects of the BTKi and/or BCL2i treatment(s).
  • Must also have an ECOG performance score of 0 or 1, which means they are able to carry out their normal daily activities without any problems.

Who cannot join

  • Heart problems.
  • Bleeding disorders.
  • Active cancer in their brain.
  • Other reasons include:.
  • Having certain treatments in the past.
  • Having certain infections that are not under control.
  • Having certain brain conditions.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

48 sites in 11 countries.

48 sites in 11 countries

United States16 sites

  • Local Institution - 0120

    Atlanta, Georgia, 30322

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • St. Luke's Mountain States Tumor Institute : Boise

    Boise, Idaho, 83712

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Local Institution - 0023

    Duarte, California, 91010

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Local Institution - 0058

    Iowa City, Iowa, 52242

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792

  • Local Institution - 0101

    Minneapolis, Minnesota, 55455

  • Local Institution - 0068

    Morgantown, West Virginia, 26506

  • Local Institution - 0121

    New York, New York, 10029

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California, 95817

  • Local Institution - 0048

    Saint Matthews, Kentucky, 40207

  • Stony Brook University

    Stony Brook, New York, 11794

Other trials in United States

France6 sites

  • Local Institution - 0035

    Clermont-Ferrand, 63100

  • Local Institution - 0038

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Local Institution - 0036

    Montpellier, Languedoc-Roussillon, 34295

  • Local Institution - 0037

    Paris, 75013

  • Local Institution - 0122

    Rennes, Brittany Region, 35033

  • Local Institution - 0034

    Toulouse, 31100

Other trials in France

Germany6 sites

  • Local Institution - 0082

    Cologne, 50937

  • Local Institution - 0084

    Dresden, Saxony, 01307

  • Local Institution - 0079

    Heidelberg, D-69120

  • Local Institution - 0083

    Kiel, Schleswig-Holstein, 24105

  • Local Institution - 0081

    Leipzig, Saxony, 04103

  • Local Institution - 0080

    Ulm, 89081

Other trials in Germany

Spain6 sites

  • Local Institution - 0104

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0105

    L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908

  • Local Institution - 0108

    Madrid, Madrid, Comunidad de, 28034

  • Local Institution - 0103

    Salamanca, 37007

  • Local Institution - 0107

    Santander, Cantabria, 39008

  • Local Institution - 0106

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

United Kingdom4 sites

  • Local Institution - 0111

    Leeds, LS9 7TF

  • Local Institution - 0115

    London, London, City of, NW1 2PG

  • Local Institution - 0109

    London, London, City of, SE5 9RS

  • Local Institution - 0110

    Oxford, 0X3 7LE

Other trials in United Kingdom

Austria2 sites

  • Local Institution - 0094

    Salzburg, 5020

  • Local Institution - 0093

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Local Institution - 0112

    Leuven, Vlaams-Brabant, 3000

  • Local Institution - 0113

    Yvoir, Namur, 5530

Other trials in Belgium

Italy2 sites

  • Local Institution - 0088

    Bologna, 40138

  • Local Institution - 0091

    Milan, Milano, 20162

Other trials in Italy

Netherlands2 sites

  • Local Institution - 0114

    Amsterdam, North Holland, 1105 AZ

  • Local Institution - 0117

    Groningen, 9713 GZ

Other trials in Netherlands

Norway1 site

  • Local Institution - 0073

    Oslo, 0372

Other trials in Norway

Sweden1 site

  • Local Institution - 0071

    Huddinge, 141 86

Other trials in Sweden

About this study

Official title: A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population)

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.

Being tested
Liso-cel, Idelalisib, Rituximab, Bendamustine, Fludarabine
Keywords
Small Lymphocytic lymphoma, B cell malignancies, CD19+ B cell malignancies, Non-Hodgkin lymphoma
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liso-celBiological

    Also called JCAR017, Breyanzi®, BMS-986387, lisocabtagene maraleucel

    Specified dose on specified days

  • IdelalisibDrug

    Also called Zydelig®

    Specified dose on specified days

  • RituximabDrug

    Also called Rituxan®, Mabthera®, Riximyo®, Truxima®

    Specified dose on specified days

  • BendamustineDrug

    Also called Bendeka®, Treanda®, Belrapzo®

    Specified dose on specified days

  • FludarabineDrug

    Also called Fludara®, Bendarabin®

    Specified dose on specified days

  • CyclophosphamideDrug

    Also called Endoxan®, Cytoxan®

    Specified dose on specified days

Study groups in NCT06205290
Study groupRoleWhat they receive
Arm A: Liso-cel MonotherapyExperimentalNot described
Receives: Biological: Liso-cel; Drug: Fludarabine; Drug: Cyclophosphamide
Arm B: Investigator's ChoiceActive comparatorNot described
Receives: Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 5 years from the last participant randomized

Secondary outcomes (23)

  1. Overall Survival (OS)

    Measured: Up to 5 years from the last participant randomized

  2. Complete Response Rate (CRR) per IRC assessment

    Measured: Up to 5 years from the last participant randomized

  3. CRR per investigators' assessment

    Measured: Up to 5 years from the last participant randomized

  4. Complete response with incomplete bone marrow recovery (CRi)

    Measured: Up to 5 years from the last participant randomized

  5. Minimal residual disease (MRD)-negativity rate

    Measured: Up to 5 years from the last participant randomized

  6. Overall Response Rate (ORR) per IRC assessment

    Measured: Up to 5 years from the last participant randomized

  7. ORR per investigators' assessment

    Measured: Up to 5 years from the last participant randomized

  8. Duration of Response (DOR) per IRC assessment

    Measured: Up to 5 years from the last participant randomized

  9. Duration of Complete Response (DOCR) per IRC assessment

    Measured: Up to 5 years from the last participant randomized

  10. PFS per investigators' assessment

    Measured: Up to 5 years from the last participant randomized

  11. Progression post next line of treatment (PFS-2)

    Measured: Up to 5 years from the last participant randomized

  12. Number of participants with Adverse Events (AEs)

    Measured: Up to 5 years from the last participant randomized

  13. Number of participants with Adverse Events of Special Interest (AESIs)

    Measured: Up to 5 years from the last participant randomized

  14. Number of participants with laboratory abnormalities

    Measured: Up to 5 years from the last participant randomized

  15. Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)

    The following domains on the EORTC QLQ-C30 will be assessed:

    • Fatigue
    • Physical functioning
    • Role functioning
    • Cognitive functioning
    • Global health status/quality of life (GHS/QoL)

    Measured: Up to 5 years from the last participant randomized

  16. Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Quality of Life Module Chronic Lymphocytic Leukemia 17 (EORTC QLQ-CLL17)

    The following domains on the EORTC QLQ-CLL17 will be assessed:

    • Symptom burden
    • Physical condition/fatigue

    Measured: Up to 5 years from the last participant randomized

  17. Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL

    As assessed by EORTC QLQ-C30

    Measured: Up to 5 years from the last participant randomized

  18. Mean changes from baseline in the following key HRQoL domains: Fatigue

    As assessed by EORTC QLQ-C30

    Measured: Up to 5 years from the last participant randomized

  19. Mean changes from baseline in the following key HRQoL domains: Physical functioning

    As assessed by EORTC QLQ-C30

    Measured: Up to 5 years from the last participant randomized

  20. Mean changes from baseline in the following key HRQoL domains: Role functioning

    As assessed by EORTC QLQ-C30

    Measured: Up to 5 years from the last participant randomized

  21. Mean changes from baseline in the following key HRQoL domains: Cognitive functioning

    As assessed by EORTC QLQ-C30

    Measured: Up to 5 years from the last participant randomized

  22. Mean changes from baseline in the following key HRQoL domains: Symptom burden

    As assessed by EORTC QLQ-CLL17

    Measured: Up to 5 years from the last participant randomized

  23. Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue

    As assessed by EORTC QLQ-CLL17

    Measured: Up to 5 years from the last participant randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start16 Jan 2024 (estimated)
  3. Primary completion13 Oct 2031 (estimated)
  4. Study completion13 Oct 2031 (estimated)

Why it stopped: Business objectives have changed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205290
Sponsor's protocol ID
CA082-1170
Status last verified
Mar 2024
First submitted
19 Dec 2023
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liso-cel, Idelalisib and Rituximab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 48 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, France, Germany, Spain, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) per independent review committee (IRC) assessment (time frame: Up to 5 years from the last participant randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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