Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19

Conditions
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Leukemia

Intervention / Treatment
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* Biological: allogeneic CART-19


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: allogeneic CART-19<br>infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19) | Biological: allogeneic CART-19<br>* allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Disease-free survival |  | up to 24 weeks | 
| Overall survival |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CART, ALL, Relapsed, Refractory, CD19+