Clinical Trials /

Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia

NCT03624036

Description:

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).

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of KTE-C19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia
  • Official Title: A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: KTE-C19-108
  • SECONDARY ID: 2018-001923-38
  • NCT ID: NCT03624036

Conditions

  • Relapsed/Refractory Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
KTE-C19KTE-C19
FludarabineKTE-C19
CyclophosphamideKTE-C19

Purpose

The primary objective of this study is to evaluate the safety (Phase 1) and efficacy (Phase 2) of KTE-C19 in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL).

Trial Arms

NameTypeDescriptionInterventions
KTE-C19ExperimentalParticipants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, KTE-C19.
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        Key Inclusion Criteria:

          -  Documentation of relapsed or refractory CLL AND a minimum of two prior treatment
             regimens with progression on treatment with ibrutinib

          -  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

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame:Up to 28 days
Safety Issue:
Description:Dose-limiting toxicity is defined as protocol-defined KTE-C19-related events with onset within the first 28 days following KTE-C19 infusion.

Secondary Outcome Measures

Measure:Complete Response (CR/CRi) Rate per Independent Review
Time Frame:Up to 15 years
Safety Issue:
Description:Complete response rate is defined per the IWCLL 2018 criteria.
Measure:Objective Response Rate (ORR) per Investigator Review
Time Frame:Up to 15 years
Safety Issue:
Description:Objective response rate is defined per the IWCLL 2018 criteria.
Measure:Complete Response Rate (CR/CRi) per Investigator Review
Time Frame:Up to 15 years
Safety Issue:
Description:Complete response rate is defined per the IWCLL 2018 criteria.
Measure:Minimal Residual Disease Negative (MRD-) Rate
Time Frame:Up to 15 years
Safety Issue:
Description:MRD- rate is defined per the IWCLL 2018 criteria.
Measure:Incidence of MRD- Among Participants who have Achieved CR or CRi
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 15 years
Safety Issue:
Description:DOR is defined as the time from first objective response to relapse or death.
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 15 years
Safety Issue:
Description:PFS is defined as the time from the KTE-C19 infusion date to the date of disease progression or death from any cause.
Measure:Overall Survival
Time Frame:Up to 15 years
Safety Issue:
Description:Overall survival is defined as the time from the KTE-C19 infusion to the date of death from any cause.
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Percentage of Participants Experiencing Clinically Significant Changes in Laboratory Values
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description: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.
Measure:Phase 2: Change from Baseline in Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu)
Time Frame:Baseline and up to 15 years
Safety Issue:
Description: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.
Measure:Phase 1: Objective Response Rate per Independent Review
Time Frame:Up to 15 years
Safety Issue:
Description:Objective response rate is defined per the IWCLL 2018 criteria.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Kite, A Gilead Company

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