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

NCT ID: NCT03331198

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2027-11-26

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib, or JCAR017 + venetoclax Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 JCAR017 monotherapy

Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)

Group Type EXPERIMENTAL

JCAR017 (lisocabtagene maraleucel)

Intervention Type 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 + ibrutinib

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

Group Type EXPERIMENTAL

JCAR017 (lisocabtagene maraleucel) + ibrutinib

Intervention Type BIOLOGICAL

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.

Phase 2 JCAR017 monotherapy

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

Group Type EXPERIMENTAL

JCAR017 (lisocabtagene maraleucel)

Intervention Type 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 + venetoclax

Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.

Group Type EXPERIMENTAL

JCAR017 (lisocabtagene maraleucel) + venetoclax

Intervention Type BIOLOGICAL

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.

Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)

Subjects will receive JCAR017 monotherapy

Group Type EXPERIMENTAL

JCAR017 (lisocabtagene maraleucel)

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
* Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:

1. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
2. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
3. DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.
* 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-α \[TNFα\], 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 or covalent and non-covalent BTKi 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

City of Hope

Duarte, California, United States

Site Status RECRUITING

City Of Hope

Duarte, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

University Of California San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Local Institution - 0059

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Local Institution - 0010

San Francisco, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Local Institution - 0110

Newark, Delaware, United States

Site Status WITHDRAWN

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Local Institution - 0085

Washington D.C., District of Columbia, United States

Site Status COMPLETED

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Local Institution - 0104

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0019

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

The Blood and Marrow Transplant Group of Georgia (BMTGA)

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

University Of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)

Indianapolis, Indiana, United States

Site Status RECRUITING

Local Institution - 0107

Wichita, Kansas, United States

Site Status NOT_YET_RECRUITING

Norton Healthcare - Norton Cancer Institute

Louisville, Kentucky, United States

Site Status RECRUITING

Local Institution - 0027

New Orleans, Louisiana, United States

Site Status COMPLETED

Local Institution - 0005

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Local Institution - 0015

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

University Of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Local Institution - 0062

Detroit, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 0109

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

University Of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Astera Cancer Care

Edison, New Jersey, United States

Site Status RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Local Institution - 0077

New Brunswick, New Jersey, United States

Site Status COMPLETED

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Local Institution - 0035

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Columbia University Medical Center

New York, New York, United States

Site Status WITHDRAWN

Local Institution - 0026

New York, New York, United States

Site Status COMPLETED

Weill Cornell Medical College

New York, New York, United States

Site Status RECRUITING

Stony Brook University

Stony Brook, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

University Hospitals Seidman Cancer Center (Case Western)

Cleveland, Ohio, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Local Institution - 0098

Eugene, Oregon, United States

Site Status COMPLETED

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Local Institution - 0029

Pittsburgh, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Baylor University Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Local Institution - 0083

Dallas, Texas, United States

Site Status COMPLETED

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Local Institution - 0079

Dallas, Texas, United States

Site Status COMPLETED

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status RECRUITING

Local Institution - 0028

Salt Lake City, Utah, United States

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 0113

Charlottesville, Virginia, United States

Site Status WITHDRAWN

Local Institution - 0087

Richmond, Virginia, United States

Site Status COMPLETED

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status WITHDRAWN

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status RECRUITING

Local Institution - 0018

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Froedtert Hospital BMT Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Local Institution - 0112

Toronto, Ontario, Canada

Site Status WITHDRAWN

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain the NCT# and Site #.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tiffany Hill

Role: primary

205-996-8023

Danielle Mussey

Role: backup

205-996-1795

Amitkumar Mehta, Site 0006

Role: primary

205-996-8400

Brenda Noggy

Role: primary

480-256-3425

Matthew Ulrickson, Site 0043

Role: primary

480-256-4749

Hormoz Mirshkarlo, MD

Role: primary

626-256-4673 ext. 69074

Tanya Siddiqi, Site 0007

Role: primary

626-256-4673

Krisma C Montalvo

Role: primary

858-246-0386

Kimberly Aguilar

Role: backup

858-534-5201

Thomas Kipps, Site 0025

Role: primary

858-822-6135

Joy Valadez

Role: primary

310-794-6500

Anna Crosetti

Role: backup

310-794-6500

Andrew Chon

Role: primary

415-476-2351

Luke Mountjoy, Site 0111

Role: primary

Pari Ramzi

Role: primary

202-784-0038

Mohamed Kharfan-Dabaja, Site 0080

Role: primary

904-953-2000

Mohamed Kharfan-Dabaja, MD

Role: primary

904-953-2000

Teresa Banda

Role: backup

214-820-1660

Site 0104

Role: primary

Scott R Solomon, MD

Role: primary

404-255-1930

Stacey Brown

Role: backup

404-780-7965

Shuo Ma, Site 0003

Role: primary

312-927-7884

Study Coordinator

Role: primary

312-695-1301

Arezou Ireta

Role: backup

312-695-8169

Sadi Dixon, RN

Role: primary

773-702-2070

Elaine Hoekstra

Role: backup

773-884-8528

Peter Riedell, Site 0016

Role: primary

773-702-8412

Anand Tandra, Site 0105

Role: primary

317-871-0000

Site 0107

Role: primary

Don Stevens, Site 0064

Role: primary

502-899-3366

Jacob D Soumerai, MD

Role: primary

617-724-4000

Emma Logan, RN

Role: primary

617-667-5984

Pavania Elavalakanar

Role: backup

617-667-1903

U of M Cancer Answerline

Role: primary

800-865-1125

Monalisa Ghosh, Site 0084

Role: primary

734-936-4000

Joo En Kim, MPH

Role: primary

313-576-8030

Site 0109

Role: primary

Clinical Trials Referral Office

Role: primary

855-776-0015

Gabrielle Bouska

Role: backup

507-538-0586

Saad Kenderian, Site 0054

Role: primary

507-284-2511

Gail A Paulsen

Role: primary

402-559-3853

Lindsay Hicks

Role: backup

402-559-6044

Julie Vose, Site 0008

Role: primary

402-559-5600

Jae Park, Site 0001

Role: primary

646-608-3743

Edward Licitra, Site 0114

Role: primary

732-390-7750

Tatyana Feldman, Site 0038

Role: primary

973-699-2835

Kara Yannotti, RNC

Role: primary

551-996-5168

Mohamad Cherry, Site 0106

Role: primary

973-971-7906

Oona Harrigan

Role: primary

732-235-5609

Roger Strair, MD, PhD

Role: backup

732-235-4523

June Greenburg

Role: primary

212-746-2651

Koen Van Besien

Role: backup

212-746-2048

Michael Schuster, Site 0089

Role: primary

Danielle Brander, Site 0030

Role: primary

919-684-8964

Rachel Stowe

Role: primary

919-681-4769

Danielle M Brander, MD

Role: backup

919-684-8964

Paolo Caimi, MD

Role: primary

216-844-3951

Yeritza Hernandez-Collazo, MS

Role: backup

216-844-3951

Molly Gallogly, Site 0078

Role: primary

Jennifer Woyach, Site 0031

Role: primary

614-688-7942

Adam Asch, MD

Role: primary

405-271-8000

Adam Asch, Site 0082

Role: primary

405-271-4022

Stephen Schuster, Site 0088

Role: primary

215-614-1846

Stephen Schuster, MD

Role: primary

215-662-6065

Usama Gergis, Site 0032

Role: primary

917-698-4310

Allison Scott

Role: primary

215-955-5903

Linda Fukas

Role: primary

Role: backup

412-623-6037

Houston E Holmes III, MD, FACP

Role: primary

214-370-1077

Courtney Saltarski

Role: primary

214-648-7030

Farrukh Awan, MD

Role: backup

214-648-4077

William Wierda, Site 0002

Role: primary

713-745-0428

William G Wierda, MD, PhD

Role: primary

713-792-7026

Kolleen Hicks, BS

Role: primary

801-587-7604

SCCA Immunotherapy Trials Intake

Role: primary

206-606-4668

Nirav Shah, Site 0055

Role: primary

414-805-4691

Nirav Shah, MD

Role: primary

414-805-4600

Abi Vijenthira, Site 0112

Role: primary

4167901284

References

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Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.

Reference Type DERIVED
PMID: 34699592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37295445 (View on PubMed)

Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.

Reference Type DERIVED
PMID: 35610089 (View on PubMed)

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Other Identifiers

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TRANSCEND-CLL-004

Identifier Type: OTHER

Identifier Source: secondary_id

017004

Identifier Type: -

Identifier Source: org_study_id

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