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Trial record 1 of 1 for:    zuma-8
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Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624036
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Phase 1: Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
    Dose-limiting toxicity is defined as protocol-defined KTE-X19-related events with onset within the first 28 days following KTE-X19 infusion.
  • Phase 2: Objective Response Rate per Independent Review [ Time Frame: Up to 2 years ]
    Objective response rate is defined per the International Workshop on CLL (IWCLL) 2018 criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Phase 1: Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
    Dose-limiting toxicity is defined as protocol-defined KTE-C19-related events with onset within the first 28 days following KTE-C19 infusion.
  • Phase 2: Objective Response Rate per Independent Review [ Time Frame: Up to 2 years ]
    Objective response rate is defined per the International Workshop on CLL (IWCLL) 2018 criteria.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Complete Response (CR/CRi) Rate per Independent Review [ Time Frame: Up to 15 years ]
    Complete response rate is defined per the IWCLL 2018 criteria.
  • Objective Response Rate (ORR) per Investigator Review [ Time Frame: Up to 15 years ]
    Objective response rate is defined per the IWCLL 2018 criteria.
  • Complete Response Rate (CR/CRi) per Investigator Review [ Time Frame: Up to 15 years ]
    Complete response rate is defined per the IWCLL 2018 criteria.
  • Minimal Residual Disease Negative (MRD-) Rate [ Time Frame: Up to 15 years ]
    MRD- rate is defined per the IWCLL 2018 criteria.
  • Incidence of MRD- Among Participants who have Achieved CR or CRi [ Time Frame: Up to 15 years ]
  • Duration of Response (DOR) [ Time Frame: Up to 15 years ]
    DOR is defined as the time from first objective response to relapse or death.
  • Progression-Free Survival (PFS) [ Time Frame: Up to 15 years ]
    PFS is defined as the time from the KTE-X19 infusion date to the date of disease progression or death from any cause.
  • Overall Survival [ Time Frame: Up to 15 years ]
    Overall survival is defined as the time from the KTE-X19 infusion to the date of death from any cause.
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 years ]
  • Percentage of Participants Experiencing Clinically Significant Changes in Laboratory Values [ Time Frame: Up to 15 years ]
  • Phase 2: Change from Baseline in European Quality of Life Five Dimension Five Level Scale (EQ-5D) [ Time Frame: Baseline and up to 15 years ]
    The European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) is a generic measure of health status that provides a simple descriptive profile and a single index value.
  • Phase 2: Change from Baseline in Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) [ Time Frame: Baseline and up to 15 years ]
    The Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. It was developed to assess symptoms (eg, fevers, chills, night sweats, nodal swelling, fatigue) specifically relevant to participants with leukemia.
  • Phase 1: Objective Response Rate per Independent Review [ Time Frame: Up to 15 years ]
    Objective response rate is defined per the IWCLL 2018 criteria.
  • Levels of Anti-CD19 CAR T-Cells in Blood [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Complete Response (CR/CRi) Rate per Independent Review [ Time Frame: Up to 15 years ]
    Complete response rate is defined per the IWCLL 2018 criteria.
  • Objective Response Rate (ORR) per Investigator Review [ Time Frame: Up to 15 years ]
    Objective response rate is defined per the IWCLL 2018 criteria.
  • Complete Response Rate (CR/CRi) per Investigator Review [ Time Frame: Up to 15 years ]
    Complete response rate is defined per the IWCLL 2018 criteria.
  • Minimal Residual Disease Negative (MRD-) Rate [ Time Frame: Up to 15 years ]
    MRD- rate is defined per the IWCLL 2018 criteria.
  • Incidence of MRD- Among Participants who have Achieved CR or CRi [ Time Frame: Up to 15 years ]
  • Duration of Response (DOR) [ Time Frame: Up to 15 years ]
    DOR is defined as the time from first objective response to relapse or death.
  • Progression-Free Survival (PFS) [ Time Frame: Up to 15 years ]
    PFS is defined as the time from the KTE-C19 infusion date to the date of disease progression or death from any cause.
  • Overall Survival [ Time Frame: Up to 15 years ]
    Overall survival is defined as the time from the KTE-C19 infusion to the date of death from any cause.
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 years ]
  • Percentage of Participants Experiencing Clinically Significant Changes in Laboratory Values [ Time Frame: Up to 15 years ]
  • Phase 2: Change from Baseline in European Quality of Life Five Dimension Five Level Scale (EQ-5D) [ Time Frame: Baseline and up to 15 years ]
    The European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) is a generic measure of health status that provides a simple descriptive profile and a single index value.
  • Phase 2: Change from Baseline in Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) [ Time Frame: Baseline and up to 15 years ]
    The Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. It was developed to assess symptoms (eg, fevers, chills, night sweats, nodal swelling, fatigue) specifically relevant to participants with leukemia.
  • Phase 1: Objective Response Rate per Independent Review [ Time Frame: Up to 15 years ]
    Objective response rate is defined per the IWCLL 2018 criteria.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia
Official Title  ICMJE A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Brief Summary The primary objective of this study is to evaluate the safety (Phase 1) and efficacy (Phase 2) of KTE-X19 in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Biological: KTE-X19
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
  • Drug: Fludarabine
    Administered intravenously
  • Drug: Cyclophosphamide
    Administered intravenously
Study Arms  ICMJE Experimental: KTE-X19
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, KTE-X19.
Interventions:
  • Biological: KTE-X19
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2035
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Documentation of relapsed or refractory CLL; must have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.
  • An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5 cm in diameter)
  • Adequate hematologic function as indicated by:

    • Platelet count ≥ 50 × 10^9/L
    • Neutrophil count ≥ 0.5 × 10^9/L
    • Hemoglobin ≥ 8 g/dL unless lower values are attributable to CLL
  • Adequate renal, hepatic, cardiac and pulmonary function defined as:

    • Creatinine clearance (as estimated by Cockcroft-Gault) ≥ 60 mL/min
    • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 mg/dL unless subject has Gilbert's syndrome
    • Left ventricular ejection fraction (LVEF) ≥ 50%, no evidence of pericardial effusion, no New York Heart Association (NYHA) class III or IV functional classification, no clinically significant arrhythmias
    • No clinically significant pleural effusion
    • Baseline oxygen saturation > 92% on room air
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)

Key Exclusion Criteria:

  • A history of treatment including any of the following:

    • Prior CD19 directed therapy
    • Prior allogeneic hematopoietic stem cell transplant (SCT) or donor lymphocyte infusion (DLI) within 6 months prior to enrollment
  • History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, idiopathic thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA))
  • Diagnosis of Richter's transformation or a history of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch-and-wait approach is standard of care, or any other cancer that has been in remission for > 3 years prior to enrollment
  • History of severe hypersensitivity reaction attributed to aminoglycosides

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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624036
Other Study ID Numbers  ICMJE KTE-C19-108
2018-001923-38 ( 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: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2020

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