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出境医 / 临床实验 / Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Description
Brief Summary:
This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.

Condition or disease Intervention/treatment Phase
Relapsed Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia Combination Product: CD19 CART Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: study group
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
 Combination Product: CD19 CART
CD19 CART
Outcome Measures
Primary Outcome Measures :
  1. recovery rate of patients being treated with CD19CAR-T [ Time Frame: 6 months ]
    the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive
  2. Age 18 to 65 years old, both male and female;
  3. Is expected to survive more than 12 weeks;
  4. Physical condition is good: 0-1 score ECOG score;
  5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  3. Pregnancy and lactation women;
  4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  5. The Investigator believe the patients should not participate in this experiment.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lixing Wang, M.D. 86-0755-21839178 wanglixin1991@sohu.com

Locations
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China
Shenzhen University General Hospital Recruiting
Shenzhen, China, 518000
Contact: Lixing Wang, M.D.    86-0755-21839178    wanglixin1991@sohu.com   
Principal Investigator: Li Yu, M.D. Ph.D.         
Principal Investigator: Lixing Wang, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
Shenzhen University General Hospital
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019) 		recovery rate of patients being treated with CD19CAR-T [ Time Frame: 6 months ]
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title  ICMJE Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
Brief Summary This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia
Intervention  ICMJE Combination Product: CD19 CART
CD19 CART
Study Arms  ICMJE Experimental: study group
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
Intervention: Combination Product: CD19 CART
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2019) 		12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive
  2. Age 18 to 65 years old, both male and female;
  3. Is expected to survive more than 12 weeks;
  4. Physical condition is good: 0-1 score ECOG score;
  5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  3. Pregnancy and lactation women;
  4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  5. The Investigator believe the patients should not participate in this experiment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lixing Wang, M.D. 86-0755-21839178 wanglixin1991@sohu.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012879
Other Study ID Numbers  ICMJE HEM-ALL001-CART
Has Data Monitoring Committee Yes
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 Not Provided
Responsible Party Li Yu, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Shenzhen University General Hospital
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date July 2019

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

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