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出境医 / 临床实验 / CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia

CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia

Study Description
Brief Summary:
CD19 CAR-T therapy is an effective treatment choice for refractory/relapsed acute B-lymphoblastic leukemia, but relapse after CAR-T treatment still occurs and is the main reason for CAR-T treatment failure. The exhaustion of CAR-T cells and the subsequent inability to maintain CAR-T cell killing effect were major underlying factors for relapse and there was no solution so far. In this study, T cells expressing CD19 antigen (feeding T cell) were constructed and expanded in vitro. Feeding T cells and CD19 CAR-T cells were infused back into the patients sequentially to continuously stimulate CD19 CAR-T cells so as to enhance the therapeutic effect and reduce the relapse rate.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, Adult B-Cell Biological: CAR-T infusion Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Safety and Efficacy of CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia Concomitant With Infusion of CD19+T Cells as Feeding Cells
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: CAR-T infusion
CAR-T cells and feeding T cells were infused into remission patients sequentially,with 5*10e6/kg and 1*10e7/kg respectively for each cycle. Each patient underwent 3 cyles of CAR-T consolidation therapies and was followed up for 2 years.
 Biological: CAR-T infusion
Patients enrolled in this arm will receive CAR-T infusion
Outcome Measures
Primary Outcome Measures :
  1. Overall survial [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  2. Event free survival [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.


Secondary Outcome Measures :
  1. Hypocytosis [ Time Frame: 6 months ]
    Events of Hypocytosis after CAR-T infusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ph+ acute B-lymphoblastic leukemia patients having received once CD19 CAR-T therapy
  • continuously taking TKI medications
  • no chance to receive allogeneic hematopoietic stem cell transplantation
  • no severe complications
  • ECOG score less than 3

Exclusion Criteria:

  • Detection of mutations on abl gene
  • resistance to TKI medications
Contacts and Locations

Locations
Layout table for location information
China, Jiangsu
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Overall survial [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
  • Event free survival [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Hypocytosis [ Time Frame: 6 months ]
Events of Hypocytosis after CAR-T infusion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia
Official Title  ICMJE Study of Safety and Efficacy of CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia Concomitant With Infusion of CD19+T Cells as Feeding Cells
Brief Summary CD19 CAR-T therapy is an effective treatment choice for refractory/relapsed acute B-lymphoblastic leukemia, but relapse after CAR-T treatment still occurs and is the main reason for CAR-T treatment failure. The exhaustion of CAR-T cells and the subsequent inability to maintain CAR-T cell killing effect were major underlying factors for relapse and there was no solution so far. In this study, T cells expressing CD19 antigen (feeding T cell) were constructed and expanded in vitro. Feeding T cells and CD19 CAR-T cells were infused back into the patients sequentially to continuously stimulate CD19 CAR-T cells so as to enhance the therapeutic effect and reduce the relapse rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia, Adult B-Cell
Intervention  ICMJE Biological: CAR-T infusion
Patients enrolled in this arm will receive CAR-T infusion
Study Arms  ICMJE Experimental: CAR-T infusion
CAR-T cells and feeding T cells were infused into remission patients sequentially,with 5*10e6/kg and 1*10e7/kg respectively for each cycle. Each patient underwent 3 cyles of CAR-T consolidation therapies and was followed up for 2 years.
Intervention: Biological: CAR-T infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 5, 2020) 		13
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		10
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ph+ acute B-lymphoblastic leukemia patients having received once CD19 CAR-T therapy
  • continuously taking TKI medications
  • no chance to receive allogeneic hematopoietic stem cell transplantation
  • no severe complications
  • ECOG score less than 3

Exclusion Criteria:

  • Detection of mutations on abl gene
  • resistance to TKI medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984968
Other Study ID Numbers  ICMJE SZCART01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
Study Sponsor  ICMJE The First Affiliated Hospital of Soochow University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Soochow University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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