Phase I/II study of rapcabtagene autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL
Active, not recruiting
- Conditions
- DLBCL, ALL, CLL
- Registration Number
- jRCT2013210066
- Lead Sponsor
- Novartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- ECOG performance status 0-1
- DLBCL diagnosis by local histopathology
- DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
- Refractory or relapsed CD19-positive ALL
- ALL with morphologic disease in the bone marrow
- 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis:
- IPI score of 3, 4 or 5
- MYC and BCL2 and/or BCL6 rearrangement (DH/THL)
Exclusion Criteria
- Prior CD19-directed therapy
- Prior administration of a genetically engineered cellular product
- Prior allogeneic HSCT
- Richter's transformation
- Active CNS lymphoma
- Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Dose recommendation 24 months incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
Safety 24 months incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
Tolerability 24 months ibrutinib dose modifications in the CLL/SLL arm
Manufacture success 24 months number of patients infused with planned target dose
Phase 2: Complete Response Rate (CRR) 24 months Complete Response Rate (CRR) as assessed by local Investigator
CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)
- Secondary Outcome Measures
Name Time Method