Leukemia Clinical Trial
Official title:
Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
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)
Status | Recruiting |
Enrollment | 10 |
Est. completion date | May 2020 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Academy of Military Medical Sciences , | Beijing | Beijing |
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences | Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | up to 24 weeks | |
Secondary | Disease-free survival | up to 24 weeks | ||
Secondary | Overall survival | up to 24 weeks |
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