Trial record 1 of 1 for:
zuma-8
Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)
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| ClinicalTrials.gov Identifier: NCT03624036 |
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Recruitment Status :
Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : February 7, 2020
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Sponsor:
Kite, A Gilead Company
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed/Refractory Chronic Lymphocytic Leukemia | Biological: KTE-X19 Drug: Fludarabine Drug: Cyclophosphamide | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 108 participants |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia |
| Actual Study Start Date : | November 15, 2018 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | September 2035 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: KTE-X19
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, KTE-X19.
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
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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
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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:
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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.
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): NCT03624036
Locations
Show 25 study locations
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
| Responsible Party: | Kite, A Gilead Company |
| ClinicalTrials.gov Identifier: | NCT03624036 |
| Other Study ID Numbers: |
KTE-C19-108 2018-001923-38 ( EudraCT Number ) |
| First Posted: | August 9, 2018 Key Record Dates |
| Last Update Posted: | February 7, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, 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 |