A Phase 1/2 Multicenter Study of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia.
- Conditions
- Relapsed/Refractory Chronic Lymphocytic LeukemiaMedDRA version: 20.0Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001923-38-ES
- Lead Sponsor
- Kite Pharma, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
101. Documentation of relapsed or refractory CLL AND a minimum of two prior treatment regimens with progression on treatment with ibrutinib
102. An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5cm in diameter)
103. Adequate hematologic function
104. Adequate renal, hepatic, cardiac and pulmonary function
105. Age 18 or older
106. ECOG performance status of 0 or 1
107. Females of childbearing potential must have a negative serum or urine pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78
201. A history of treatment including any of the following:
a. Prior CD19 directed therapy
b. Treatment with alemtuzumab within 6 months before enrollment
c. Prior allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 6 months prior to enrollment
d. Live vaccine administration within 4 weeks before enrollment
e. Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment
202. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index
203. History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, ITP, AIHA)
204. 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
205. History of severe hypersensitivity reaction attributed to aminoglycosides or any of the agents required for treatment in this study
206. CNS disease
207. History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome
208. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrolment
209. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment
210. Primary immunodeficiency
211. Known infection with HIV; chronic active hepatitis B; active hepatitis C. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative PCR or a comparable testing method.
212. Presence of active fungal, bacterial, viral infection or any infection requiring antimicrobial treatment for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical
Monitor
213. Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted
217. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase 1: Evaluate the safety of KTE-X19 <br>Phase 2: Evaluate the efficacy of KTE-X19 as measured by the objective response rate (ORR) per independent review;Secondary Objective: Characterize the safety profile and assess additional efficacy endpoints;Primary end point(s): Phase 1: Incidence of DLTs in subjects treated with KTE-X19 <br>Phase 2: Objective response rate (CR/CRi/PR) per independent review as defined by IWCLL 2018 criteria;Timepoint(s) of evaluation of this end point: Phase 1: onset within the first 28 days following KTE-X19 infusion<br>Phase 2: Disease assessment at D28, W8, M3
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Complete response (CR/CRi) rate,<br>ORR per investigator review<br>Minimum Residual Disease (MRD) Negative Rate<br>CR/CRi with MRD- (CR/MRD-) rate<br>Duration of response (DOR), <br>Progression-free survival (PFS)<br>Overall survival (OS)<br>Incidence of AEs and clinically significant changes in laboratory values<br>Changes in EQ-5D and FACT-Leu;Timepoint(s) of evaluation of this end point: Disease Assessment at D28, W8, M3, M6, then every 3 months till M24, then every 6 months till M60, them annually through Year 15<br>Safety: onset on or after the KTE-X19 infusion, through the study