Leukemia
Conditions
Keywords
CART, ALL, Relapsed, Refractory, CD19+
Brief summary
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)
Detailed description
The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
Interventions
BIOLOGICALallogeneic CART-19
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Sponsors
Chinese PLA General Hospital
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years * Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL) * Estimated life expectancy ≥ 12 weeks (according to investigator's judgment) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion criteria
* Previous treatment with investigational gene or cell therapy medicine products * CD19 negative B-cell leukemia * Any uncontrolled active medical disorder that would preclude participation as outlined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of study related adverse events | 1 year | defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate of allogeneic CART-19 | up to 24 weeks | An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR |
| Disease-free survival | up to 24 weeks | — |
| Overall survival | up to 24 weeks | — |
Countries
China
Contacts
Primary ContactHuisheng Ai, MD
Outcome results
None listed