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Trial record 1 of 1 for:    NCT03105336
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A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)

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ClinicalTrials.gov Identifier: NCT03105336
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE June 20, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Objective response rate [ Time Frame: 6 months ]
Complete response (CR) + partial response (PR) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007) as determined by the study investigators.
Change History Complete list of historical versions of study NCT03105336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • 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)
  • 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.
  • 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.
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to 15 years ]
    OS is defined as the time from KTE-C19 infusion to the date of death.
  • 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. ]
  • 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 ]
  • Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies [ Time Frame: At enrollment, Week 4, Month 3, every 3 months up to Month 12 ]
  • Percentage of Participants Experiencing clinically significant changes in lab values [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Progression Free Survival [ Time Frame: 12 months ]
    The time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007) or death from any cause.
  • Overall Survival [ Time Frame: 12 months ]
    Defined as the time from axicabtagene ciloleucel infusion to the date of death.
  • Incidences of AEs [ Time Frame: 12 months ]
    The frequency of any AEs that occurred during study participation.
  • Clinical significant changes in lab values. [ Time Frame: 12 months ]
    The occurrence of any changes in lab values deemed to be clinically significant during study participation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Official Title  ICMJE A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Indolent Non-Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: axicabtagene ciloleucel
Interventions:
  • Biological: axicabtagene ciloleucel
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2017)
50
Estimated Study Completion Date  ICMJE March 2035
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Information 1-844-454-5483(1-844-454-KITE) medinfo@kitepharma.com
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105336
Other Study ID Numbers  ICMJE KTE-C19-105
2017-001912-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences ( Kite, A Gilead Company )
Study Sponsor  ICMJE Kite, A Gilead Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kite Study Director Kite, A Gilead Company
PRS Account Gilead Sciences
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP