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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title:

An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331198
• Other study ID #: 017004
• Secondary ID: TRANSCEND-CLL-00
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 27, 2017
• Est. completion date: November 26, 2027

Study information

• Verified date: April 2024
• Source: Juno Therapeutics, a Subsidiary of Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 209
• Est. completion date: November 26, 2027
• Est. primary completion date: November 26, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of:

1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or

2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)

• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must

have received previous treatment as follows:

1. Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.

2. Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.

• Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:

1. be receiving ibrutinib and progressing at the time of study enrollment

2. be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a

3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib

4. have previously received ibrutinib and have no contraindications to restarting ibrutinib

• Eastern Cooperative Oncology Group performance status of = 1
• Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy
• Adequate organ function, defined as:

1. Serum creatinine = 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min

2. Alanine aminotransferase = 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)

3. Adequate pulmonary function, defined as = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) = 92% on room air

4. Adequate cardiac function, defined as left ventricular ejection fraction = 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility

• Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
• If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
• Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax
• Subjects in venetoclax + JCAR017 combination cohort must:

1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi

2. be venetoclax naive (required for dose expansion) or

3. if prior venetoclax (only for dose escalation)

4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation

• subjects in the venetoclax + JCAR017 combination must have hemoglobin >=9 g/dL, absolute neutrophil count >=500mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
• must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes =1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

Exclusion Criteria:

• 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:

1. Alemtuzumab within 6 months prior to leukapheresis

2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis

3. Cladribine within 3 months prior to leukapheresis

4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis

5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis

6. Fludarabine within 4 weeks prior to leukapheresis

7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-a [TNFa], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis

8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis

9. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis

10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis

11. Venetoclax within 4 days prior to leukapheresis

12. Idelalisib or duvelisib within 2 days prior to leukapheresis

13. Lenalidomide within 1 day prior to leukapheresis

14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis

• Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
• Progressive vascular tumor invasion, thrombosis, or embolism
• Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
• Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
• Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
• For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Related Conditions & MeSH terms

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

Intervention

Biological:
• JCAR017 (lisocabtagene maraleucel)
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.
• JCAR017 (lisocabtagene maraleucel) + ibrutinib
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
• JCAR017 (lisocabtagene maraleucel) + venetoclax
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.

Locations

Country	Name	City	State
United States	Local Institution - 0084	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Local Institution - 0019	Atlanta	Georgia
United States	The Blood and Marrow Transplant Group of Georgia (BMTGA)	Atlanta	Georgia
United States	Local Institution - 0006	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Local Institution - 0005	Boston	Massachusetts
United States	Local Institution - 0015	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Local Institution - 0003	Chicago	Illinois
United States	Local Institution - 0016	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Local Institution - 0078	Cleveland	Ohio
United States	University Hospitals Seidman Cancer Center (Case Western)	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Local Institution - 0079	Dallas	Texas
United States	Local Institution - 0083	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Local Institution - 0062	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Local Institution - 0007	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Local Institution - 0098	Eugene	Oregon
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Local Institution - 0043	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Local Institution - 0038	Hackensack	New Jersey
United States	Local Institution - 0002	Houston	Texas
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Local Institution - 0080	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	Local Institution - 0025	La Jolla	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Local Institution - 0059	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Local Institution - 0055	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Local Institution - 0077	New Brunswick	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Local Institution - 0026	New York	New York
United States	Local Institution - 0035	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Local Institution - 0082	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center (Stephenson Cancer Center)	Oklahoma City	Oklahoma
United States	Local Institution - 0008	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Local Institution - 0032	Philadelphia	Pennsylvania
United States	Local Institution - 0088	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Local Institution - 0029	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Local Institution - 0087	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Local Institution - 0054	Rochester	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Local Institution - 0028	Salt Lake City	Utah
United States	Local Institution - 0010	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Local Institution - 0018	Seattle	Washington
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Local Institution - 0085	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Juno Therapeutics, a Subsidiary of Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 JCAR017 monotherapy arm: adverse events	Proportion of subjects experiencing adverse events	Up to 48 months post treatment
Primary	Phase 1 JCAR017 monotherapy arm: laboratory abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Primary	Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events	Proportion of subjects experiencing adverse events	Up to 48 months post treatment
Primary	Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Primary	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
Primary	Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events	Proportion of subjects experiencing adverse events	Up to 48 months post treatment
Primary	Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Primary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm	Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines	Through post treatment up to Month 48
Primary	Phase 2 JCAR017 monotherapy expansion arm	Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines	Through post treatment up to Month 48
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events	Proportion of subjects experiencing adverse events	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR	Defined as the rate of CR (including CRi)	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood	Proportion of subjects who achieve MRD CR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood	Proportion of subjects who achieve MRD CR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR)	Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR)	Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR)	Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR)	Defined as the interval from JCAR017 infusion to the first documentation of CR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS	Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS	Defined as the time from JCAR017 infusion to the date of death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events	Proportion of subject experiencing adverse events	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR	Defined as the rate of CR (including CRi)	Through post treatment Day 90
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood	Proportion of subjects who achieve MRD CR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood	Proportion of subjects who achieve MRD CR	Through post treatment Day 90
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR)	Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR)	Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR)	Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR)	Defined as the interval from JCAR017 infusion to the first documentation of CR	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS	Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS	Defined as the time from JCAR017 infusion to the date of death due to any cause	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events	Proportion of subjects experiencing adverse events	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities	Proportion of subjects experiencing laboratory abnormalities	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: ORR	Defined as the rate of CR (including CRi)	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood	Proportion of subjects who achieve MRD CR	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood	Proportion of subjects who achieve MRD CR	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR)	Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR)	Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR)	Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR)	Defined as the interval from JCAR017 infusion to the first documentation of CR	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: PFS	Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: OS	Defined as the time from JCAR017 infusion to the date of death due to any cause	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire	Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire	Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire	Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire	Proportion of participants with intensive care unit (ICU) inpatient days	Up to 48 months post treatment
Secondary	Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire	Proportion of participants with non-ICU inpatient days	Up to 48 months post treatment

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting