Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ZUMA-5
Previous Study | Return to List | Next Study

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105336
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Brief Summary:
This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Marginal Zone Lymphoma Indolent Non-Hodgkin Lymphoma Biological: axicabtagene ciloleucel Drug: Cyclophosphamide Drug: Fludarabine Phase 2

Detailed Description:

This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

All enrolled subjects will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, subjects will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After the product is manufactured and conditioning chemotherapy period is complete, subjects will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. Subjects will be followed by their study doctor for continued monitoring of the safety and effectiveness of the study treatment for approximately 3 months after receiving treatment and then will be followed for safety for up to an additional 15 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2035


Arm Intervention/treatment
Experimental: axicabtagene ciloleucel Biological: axicabtagene ciloleucel
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
Other Name: Yescarta®

Drug: Cyclophosphamide
Administered intravenously

Drug: Fludarabine
Administered intravenously




Primary Outcome Measures :
  1. Objective response rate per central read [ Time Frame: Up to 15 years ]
    Complete response (CR) + partial response (PR) per the Lugano Classiciation (Cheson et al, 2014).


Secondary Outcome Measures :
  1. CR Rate per central read [ Time Frame: Up to 15 years ]
    CRR is defined as the incidence of CR as best response to treatment by the Lugano Classification (Cheson et al, 2014)

  2. DOR [ Time Frame: Up to 15 years ]
    DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression per (Cheson et al, 2014) or disease-related death, whichever comes first.

  3. PFS [ Time Frame: Up to 15 years ]
    PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per (Cheson et al, 2014) or death from any cause.

  4. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 2 years ]
  5. Overall Survival (OS) [ Time Frame: Up to 15 years ]
    OS is defined as the time from KTE-C19 infusion to the date of death.

  6. Levels of anti-CD19 CAR T cells in blood [ Time Frame: At enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5. ]
  7. Levels of cytokines in serum [ Time Frame: At enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4 ]
  8. Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies [ Time Frame: At enrollment, Week 4, Month 3, every 3 months up to Month 12 ]
  9. Percentage of Participants Experiencing clinically significant changes in lab values [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Individual has [follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP).
  2. Individual has [measurable disease].
  3. Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
  4. If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
  5. Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
  6. Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 6 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).

Key Exclusion Criteria:

  1. Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
  2. Small lymphocytic lymphoma
  3. Histological Grade 3b FL
  4. Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
  5. Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105336


Contacts
Layout table for location contacts
Contact: Medical Information 1-844-454-5483(1-844-454-KITE) medinfo@kitepharma.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
Layout table for investigator information
Study Director: Kite Study Director Kite, A Gilead Company

Layout table for additonal information
Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT03105336    
Other Study ID Numbers: KTE-C19-105
2017-001912-13 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites