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

Primary Purpose

Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
allogeneic CART-19
Sponsored by
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring CART, ALL, Relapsed, Refractory, CD19+

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Academy of Military Medical Sciences ,Recruiting
  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

allogeneic CART-19

Arm Description

infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Disease-free survival
Overall survival

Full Information

First Posted
May 31, 2016
Last Updated
February 21, 2019
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02799550
Brief Title
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
Official Title
Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
CART, ALL, Relapsed, Refractory, CD19+

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
allogeneic CART-19
Arm Type
Experimental
Arm Description
infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Intervention Type
Biological
Intervention Name(s)
allogeneic CART-19
Intervention Description
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Primary Outcome Measure Information:
Title
Occurrence of study related adverse events
Description
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
Secondary Outcome Measure Information:
Title
Overall response rate of allogeneic CART-19
Description
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
Title
Disease-free survival
Time Frame
up to 24 weeks
Title
Overall survival
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huisheng Ai, MD
Phone
861066947135
Email
huishengai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisheng Ai, MD
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences ,
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huisheng Ai, MD
Phone
86-1066947126
Email
huishengai@163.com
First Name & Middle Initial & Last Name & Degree
Huisheng Ai, MD
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han, MD
Phone
86-13651392893
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name & Degree
Weidong Han, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27887660
Citation
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.
Results Reference
derived

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

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