Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
1 other identifier
interventional
10
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 leukemia
Started Oct 2015
Typical duration for phase_1 leukemia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFebruary 25, 2019
June 1, 2018
3.6 years
May 31, 2016
February 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (3)
Overall response rate of allogeneic CART-19
up to 24 weeks
Disease-free survival
up to 24 weeks
Overall survival
up to 24 weeks
Study Arms (1)
allogeneic CART-19
EXPERIMENTALinfusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Interventions
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing 100071, 100071, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
Cai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z.
PMID: 27887660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huisheng Ai, MD
Affiliated Hospital of Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 15, 2016
Study Start
October 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2020
Last Updated
February 25, 2019
Record last verified: 2018-06