Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

NCT ID: NCT02348216

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-21
• Study Completion Date: 2023-07-27

Brief Summary

This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

• Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
• Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
• Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

Conditions

Refractory Diffuse Large B Cell Lymphoma (DLBCL); Relapsed Diffuse Large B-Cell Lymphoma; Transformed Follicular Lymphoma (TFL); Primary Mediastinal B-cell Lymphoma (PMBCL); High Grade B-cell Lymphoma (HGBCL)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy

Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) will receive conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Pivotal Study): Cohort 1

Participants with refractory DLBCL will receive conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Pivotal Study): Cohort 2

Participants with refractory PMBCL or TFL will receive conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Safety Management Study): Cohort 3

Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL will receive conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants will also receive a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Levetiracetam

Intervention Type: DRUG

Administered according to package insert

Tocilizumab

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Safety Management Study): Cohort 4

Participants with r/r DLBCL,PMBCL,TFL,or high-grade B-cell lymphoma(HGBCL)after 2 systemic lines of therapy will receive optional bridging therapy(dexamethasone 20mg to 40mg,eitherorally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP)for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1),conditioning chemotherapy(fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3;followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants will receive a prophylactic regimen of levetiracetam(750 mg orally or IV twice daily(BID)starting on Day 0).Participants will receive tocilizumab(initiated on persistent Grade 1 cytokine release syndrome(CRS)for over 24 hours)and dexamethasone(persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Levetiracetam

Intervention Type: DRUG

Administered according to package insert

Tocilizumab

Intervention Type: DRUG

Administered according to package insert

Dexamethasone

Intervention Type: DRUG

Administered according to package insert

High-dose methylprednisolone

Intervention Type: DRUG

Administered according to package insert

Bendamustine

Intervention Type: DRUG

Administered according to package insert

Rituximab

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Safety Management Study): Cohort 5

Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy will receive debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants will also receive a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Levetiracetam

Intervention Type: DRUG

Administered according to package insert

Rituximab

Intervention Type: DRUG

Administered according to package insert

Doxorubicin

Intervention Type: DRUG

Administered according to package insert

Prednisone

Intervention Type: DRUG

Administered according to package insert

Vincristine

Intervention Type: DRUG

Administered according to package insert

Ifosfamide

Intervention Type: DRUG

Administered according to package insert

Carboplatin

Intervention Type: DRUG

Administered according to package insert

Etoposide

Intervention Type: DRUG

Administered according to package insert

Gemcitabine

Intervention Type: DRUG

Administered according to package insert

Oxaliplatin

Intervention Type: DRUG

Administered according to package insert

Cisplatin

Intervention Type: DRUG

Administered according to package insert

Phase 2 (Safety Management Study): Cohort 6

Participants with r/r DLBCL,PMBCL,TFL orHGBCL after 2 systemic lines of therapy may receive bridging therapy(dexamethasone 20mg to 40mg,orally or IV daily for 1 to 4 days or 1g/m\^2 HDMP for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1),conditioning chemotherapy(fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.Participants will also receive a prophylactic regimen of levetiracetam 750 mg orally or IV twice daily(BID)starting on Day 0)and corticosteroids(dexamethasone, 10 mg once daily on Days 0, 1, and 2).Participants will receive tocilizumab(initiated on persistent Grade 1 CRS for over 24 hours)and dexamethasone(persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Levetiracetam

Intervention Type: DRUG

Administered according to package insert

Tocilizumab

Intervention Type: DRUG

Administered according to package insert

Dexamethasone

Intervention Type: DRUG

Administered according to package insert

High-dose methylprednisolone

Intervention Type: DRUG

Administered according to package insert

Bendamustine

Intervention Type: DRUG

Administered according to package insert

Rituximab

Intervention Type: DRUG

Administered according to package insert

Methylprednisolone

Intervention Type: DRUG

Administered according to package insert

Interventions

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Intervention Type: BIOLOGICAL

Fludarabine

Administered according to package insert

Intervention Type: DRUG

Cyclophosphamide

Administered according to package insert

Intervention Type: DRUG

Levetiracetam

Administered according to package insert

Intervention Type: DRUG

Tocilizumab

Administered according to package insert

Intervention Type: DRUG

Dexamethasone

Administered according to package insert

Intervention Type: DRUG

High-dose methylprednisolone

Administered according to package insert

Intervention Type: DRUG

Bendamustine

Administered according to package insert

Intervention Type: DRUG

Rituximab

Administered according to package insert

Intervention Type: DRUG

Doxorubicin

Administered according to package insert

Intervention Type: DRUG

Prednisone

Administered according to package insert

Intervention Type: DRUG

Vincristine

Administered according to package insert

Intervention Type: DRUG

Ifosfamide

Administered according to package insert

Intervention Type: DRUG

Carboplatin

Administered according to package insert

Intervention Type: DRUG

Etoposide

Administered according to package insert

Intervention Type: DRUG

Gemcitabine

Administered according to package insert

Intervention Type: DRUG

Oxaliplatin

Administered according to package insert

Intervention Type: DRUG

Cisplatin

Administered according to package insert

Intervention Type: DRUG

Methylprednisolone

Administered according to package insert

Intervention Type: DRUG

Other Intervention Names

Yescarta®

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed:

• Diffuse Large B Cell Lymphoma (DLBCL)
• Primary Mediastinal Large B Cell Lymphoma (PMBCL)
• Transformation Follicular Lymphoma (TFL)
• High grade B-cell lymphoma (HGBCL)

2. Chemotherapy-refractory disease, defined as one of more of the following:

• No response to last line of therapy i. Progressive disease (PD) as best response to most recent therapy regimen ii. Stable disease (SD) as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR
• Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy

3. Individuals must have received adequate prior therapy including at a minimum:

• Anti-cluster of differentiate 20 (CD20) monoclonal antibody unless investigator determines that tumor is CD20-negative and
• an anthracycline containing chemotherapy regimen
• for individual with transformed FL must have chemorefractory disease after transformation to DLBCL.

4. At least one measurable lesion per revised international working group (IWG Response Criteria

5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1

6. Absolute neutrophil count (ANC) ≥ 1000/microliters (uL)

7. Absolute lymphocyte count ≥ 100/uL

8. Platelet count ≥ 75,000/uL

9. Adequate renal, hepatic, pulmonary and cardiac function defined as:

• Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min
• Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 upper limit of normal (ULN)
• Total bilirubin < 1.5 mg/dL, except in individuals with Gilbert's syndrome
• Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant pleural effusion
• Baseline oxygen saturation >92% on room air

10. All individuals or legally appointed representatives/caregivers, must personally sign and date the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent form before initiating any study specific procedures or activities.

11. Relapsed or refractory large B-cell lymphoma including DLBCL, PMBCL, TFL, and HGBCL after two systemic lines of therapy

Exclusion Criteria

1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years

2. History of allogeneic stem cell transplantation

3. Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy

4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment

5. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection. Individuals with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines

6. Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases

7. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kite, A Gilead Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kite Study Director

Role: STUDY_DIRECTOR

Kite, A Gilead Company

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

University of California San Diego (UCSD)

La Jolla, California, United States

Stanford University

Palo Alto, California, United States

University of California Los Angeles (UCLA)

Santa Monica, California, United States

Sarah Cannon - Denver

Denver, Colorado, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Rochester

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States

Sarah Cannon - Tennesee

Nashville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Sarah Cannon-Methodist Healthcare System - San Antonio

San Antonio, Texas, United States

Vancouver General Hospital

Vancouver, British Columbia, Canada

Princess Margaret

Toronto, Ontario, Canada

Hopital Saint Louis

Paris, , France

Hopital Haut-Leveque

Pessac, , France

CHU de Rennes

Rennes, , France

Universitätsklinik Dresden

Dresden, , Germany

University Hospital of Essen

Essen, , Germany

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Tel Aviv Souraski Medical Center

Tel Aviv, , Israel

Academisch Medisch Centrum

Amsterdam, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

United States; Canada; France; Germany; Israel; Netherlands

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Reference Type: DERIVED

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Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. doi: 10.1016/S1470-2045(18)30864-7. Epub 2018 Dec 2.

Reference Type: DERIVED

PMID: 30518502 (View on PubMed)

Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.

Reference Type: DERIVED

PMID: 29226797 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Amendment 8

View Document

Document Type: Study Protocol: Amendment 10

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study/?id=KTE-C19-101

Gilead Clinical Trials Website

Other Identifiers

2015-005007-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KTE-C19-101

Identifier Type: -

Identifier Source: org_study_id