A Phase 1 interventional study of allogeneic CART-19 in Leukemia, sponsored by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences. Status unknown at 2 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Phase 1, Interventional, and Treatment
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)
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →The Affiliated Hospital of the Chinese Academy of Military Medical Sciences is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Biological: allogeneic CART-19
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Occurrence of study related adverse events
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
Time frame: 1 year
Overall response rate of allogeneic CART-19
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
Time frame: up to 24 weeks
Disease-free survival
Time frame: up to 24 weeks
Overall survival
Time frame: up to 24 weeks
Plan to share: Undecided
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences