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Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258047
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Wenbin Qian, First Affiliated Hospital of Zhejiang University

Tracking Information
First Submitted Date  ICMJE August 20, 2017
First Posted Date  ICMJE August 22, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date January 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
complete remission rate [ Time Frame: every 3 months until 20 months after the last patient's enrollment ]
complete remission rate after treated by CAR-T therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • progression free survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment ]
    from date of inclusion to date of progression, relapse, or death from any cause
  • overall survival [ Time Frame: 20 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause
  • adverse events [ Time Frame: from the date of the start of treatment to 20 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
  • duration of the modified T cells by CAR-T in the patients [ Time Frame: from the date of re-transfusison to 20 months after last patient's enrollment ]
    time from re-transfusion to date when the modified T cells become non-detectable.
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 Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Official Title  ICMJE Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Brief Summary

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

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 B Cell Lymphoma
Intervention  ICMJE Combination Product: CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
Study Arms  ICMJE Experimental: CAR-T treatment
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
Intervention: Combination Product: CAR-T
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
Estimated Enrollment  ICMJE
 (submitted: August 21, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date January 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age≥18 years, male or female;
  2. Karnofsky≥60%;
  3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
  4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
  5. Patients have had more than 2 combined chemotherapy regimens;
  6. Creatinin <2.5mg/dL;ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL;
  7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
  8. Patient that could understand and is willing to sign the written consent;
  9. Fertile female patient should be willing to take contraceptive measures.
  10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria:

  1. Patients who need ≥15mg prednisone daily due to any cause;
  2. Patients with autoimmune disease and need immunosuppressor treatment;
  3. Serum creatinin>2.5 mg/dL;serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
  4. FEV1<2 L,diffusion capacity for carbon monoxide of lung (DLCO) <40%;
  5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%;
  6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
  7. Patients that have previously received gene therapy of any kind;
  8. Obvious clinical encephalopathy or novel neuron function damage;
  9. Patients with active infection;
  10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
  11. Patients who had allergic history to agents of the similar structure as CAR-T;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT03258047
Other Study ID Numbers  ICMJE lymphoma center Q002
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: Yes
Plan Description: All the data would be available on the corresponding website of the leading research center.
Responsible Party Wenbin Qian, First Affiliated Hospital of Zhejiang University
Study Sponsor  ICMJE First Affiliated Hospital of Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date February 2019

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