Trials Sponsors Conditions Drugs Pricing

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Small Lymphocytic

Keywords

TRANSCEND_CLL_004

Outcome Measures

Primary Outcomes (10)

Phase 1 JCAR017 monotherapy arm: adverse events
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 monotherapy arm: laboratory abnormalities
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm
Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines
Through post treatment up to Month 48

Secondary Outcomes (48)

Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood
Up to 48 months post treatment
+43 more secondary outcomes

Study Arms (5)

Phase 1 JCAR017 monotherapy

EXPERIMENTAL

Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)

Biological: JCAR017 (lisocabtagene maraleucel)

Phase 1 JCAR017 + ibrutinib

EXPERIMENTAL

Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib

Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib

Phase 2 JCAR017 monotherapy

EXPERIMENTAL

Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm

Interventions

JCAR017 (lisocabtagene maraleucel)Biological

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

Phase 1 JCAR017 monotherapyPhase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)Phase 2 JCAR017 monotherapy

JCAR017 (lisocabtagene maraleucel) + ibrutinibBiological

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of:
CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or

Sponsors & Collaborators

Juno Therapeutics, a Subsidiary of Celgene
Industrylead

Study Sites (84)

Local Institution - 0006

Birmingham, Alabama, 35294, United States

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Local Institution - 0043

Gilbert, Arizona, 85234, United States

City of Hope

Duarte, California, 91010, United States

Local Institution - 0007

Duarte, California, 91010, United States

Local Institution - 0025

La Jolla, California, 92093, United States

Related Publications (4)

Wierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print.
PMID: 42520199DERIVED
Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023 Aug 19;402(10402):641-654. doi: 10.1016/S0140-6736(23)01052-8. Epub 2023 Jun 6.
PMID: 37295445

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinibvenetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Bristol-Myers Squibb
Bristol-Myers Squibb
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 6, 2017

Study Start

November 27, 2017

Actual (reported)

Primary Completion

You may not qualify if:

Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
Subjects with Richter's transformation
Prior treatment with any gene therapy product
Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
Systemic fungal, bacterial, viral, or other infection that is not controlled
Presence of acute or extensive chronic graft versus host disease (GVHD)
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
Pregnant or nursing (lactating) women
Use of any of the following medications or treatments within the noted time prior to leukapheresis:
Alemtuzumab within 6 months prior to leukapheresis
Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
Cladribine within 3 months prior to leukapheresis
Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
+16 more criteria

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (10)

Secondary Outcomes (48)

Study Arms (5)

Phase 1 JCAR017 monotherapy

Phase 1 JCAR017 + ibrutinib

Phase 2 JCAR017 monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Phase 1 JCAR017 + venetoclax

Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (10)

Secondary Outcomes (48)

Study Arms (5)

Phase 1 JCAR017 monotherapy

Phase 1 JCAR017 + ibrutinib

Phase 2 JCAR017 monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Phase 1 JCAR017 + venetoclax

Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)

You may not qualify if:

Data Sharing

Source record

Locations