Back to resultsChimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Age: 18-65 years
- Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
- Refractory or relapsed B cell-acute lymphoblastic leukemia
- No available curative treatment options (such as hematopoietic stem cell transplantation)
- Stage III-IV disease
- Creatinine < 2.5 mg/dl
- Aspartate transaminase-alanine transaminase ratio < 3x normal
- Bilirubin < 2.0 mg/dl
- Karnofsky performance status >= 60
- Expected survival time > 3 months
- Adequate venous access for apheresis
- Ability to understand and provide informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Patients requiring T cell immunosuppressive therapy
- Active central nervous system leukemia
- Any concurrent active malignancies
- Patients with a history of a seizure disorder or cardiac disorder
- Patients with human immunodeficiency virus, hepatitis B or C infection
- Uncontrolled active infection
Sites / Locations
- Department of Hematopoietic Stem Cell TransplantationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T cells
Arm Description
Targeting CD19
Outcomes
Primary Outcome Measures
Number of Adverse Events
To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
Secondary Outcome Measures
Clinical responses to third generation CAR-T cells
To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia
Full Information
NCT ID
NCT02186860
First Posted
July 8, 2014
Last Updated
February 6, 2021
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02186860
Brief Title
Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Official Title
Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.
Detailed Description
CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T cells
Arm Type
Experimental
Arm Description
Targeting CD19
Intervention Type
Biological
Intervention Name(s)
CAR-T cells
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical responses to third generation CAR-T cells
Description
To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-65 years
Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
Refractory or relapsed B cell-acute lymphoblastic leukemia
No available curative treatment options (such as hematopoietic stem cell transplantation)
Stage III-IV disease
Creatinine < 2.5 mg/dl
Aspartate transaminase-alanine transaminase ratio < 3x normal
Bilirubin < 2.0 mg/dl
Karnofsky performance status >= 60
Expected survival time > 3 months
Adequate venous access for apheresis
Ability to understand and provide informed consent
Exclusion Criteria:
Pregnant or lactating women
Patients requiring T cell immunosuppressive therapy
Active central nervous system leukemia
Any concurrent active malignancies
Patients with a history of a seizure disorder or cardiac disorder
Patients with human immunodeficiency virus, hepatitis B or C infection
Uncontrolled active infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Sun, M.D., Ph.D.
Phone
+86-010-6694-7402
Email
suny320@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liangding Hu, M.D.
Phone
+86-010-6694-7107
Email
huliangding@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangding Hu, M.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematopoietic Stem Cell Transplantation
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Yao, M.D., Ph.D.
Phone
+86-010-6694-7402
Email
suny320@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28039295
Citation
Tang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904.
Results Reference
derived
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Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
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