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Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies

Primary Purpose

Acute Lymphoblastic Leukemia, B Cell Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic hematological stem cell transplantation
Sponsored by
Wuhan Sian Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);

  2. B cell hematological malignancies include the following three categories:

    • B-cell acute lymphocytic leukemia (B-ALL);
    • Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
    • Aggressive B-cell lymphoma (DLBCL, BL, MCL);
  3. < 70 years old;
  4. Expected survival time > 6 months;
  5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
  6. Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.

Exclusion Criteria:

  1. With a history of epilepsy or other central nervous system diseases;
  2. Previous allogeneic hematopoietic stem cell transplantation;
  3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
  4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
  5. Not curable active infection;
  6. Patients with active hepatitis B or hepatitis C virus infection;
  7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
  8. Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L);
  9. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
  10. Patients with HIV-infection;
  11. Any situation that may increase the risk of patients or interfere with test results.

Sites / Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Consolidative allo-HSCT following CAR-T therapy

Arm Description

Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.

Outcomes

Primary Outcome Measures

Number of participants with adverse events
To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)

Secondary Outcome Measures

Overall survival
OS was calculated from the date of inclusion to death or last follow-up (censored).
Event-free survival
EFS was calculated from the date of inclusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).
Relapse-free survival
RFS was calculated from the date of inclusion to relapse or last visit (censored).

Full Information

First Posted
December 1, 2017
Last Updated
May 8, 2019
Sponsor
Wuhan Sian Medical Technology Co., Ltd
Collaborators
Wuhan Union Hospital, China, Jingzhou Central Hospital, Xiangyang Central Hospital, People Hospital Of Yichang
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1. Study Identification

Unique Protocol Identification Number
NCT03366350
Brief Title
Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies
Official Title
A Phase 1/2 Study Evaluating the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy Bridging to Hematological Stem Cell Transplantation (HSCT) for Relapsed/Refractory CD19+ B-Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2016 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Sian Medical Technology Co., Ltd
Collaborators
Wuhan Union Hospital, China, Jingzhou Central Hospital, Xiangyang Central Hospital, People Hospital Of Yichang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.
Detailed Description
Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in long-term remissions, patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients receive consolidative allo-HSCT following CAR-T therapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Consolidative allo-HSCT following CAR-T therapy
Arm Type
Experimental
Arm Description
Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
Intervention Type
Procedure
Intervention Name(s)
Allogeneic hematological stem cell transplantation
Intervention Description
Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS was calculated from the date of inclusion to death or last follow-up (censored).
Time Frame
5 years
Title
Event-free survival
Description
EFS was calculated from the date of inclusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).
Time Frame
5 years
Title
Relapse-free survival
Description
RFS was calculated from the date of inclusion to relapse or last visit (censored).
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092); B cell hematological malignancies include the following three categories: B-cell acute lymphocytic leukemia (B-ALL); Indolent B-cell lymphoma (CLL, FL, MZL, LPL); Aggressive B-cell lymphoma (DLBCL, BL, MCL); < 70 years old; Expected survival time > 6 months; Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative. Exclusion Criteria: With a history of epilepsy or other central nervous system diseases; Previous allogeneic hematopoietic stem cell transplantation; The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System); Pregnant or lactating women (safety of this therapy for the unborn child is unknown); Not curable active infection; Patients with active hepatitis B or hepatitis C virus infection; Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently); Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L); Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial; Patients with HIV-infection; Any situation that may increase the risk of patients or interfere with test results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YU HU, M.D., Ph.D
Phone
86-13986183871
Email
dr_huyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
HENG MEI, M.D., Ph.D
Phone
86-13886160811
Email
mayheng@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU HU, M.D., Ph.D
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YU HU, M.D., Ph.D
Phone
86-13986183871
Email
dr_huyu@126.com
First Name & Middle Initial & Last Name & Degree
HENG MEI, M.D., Ph.D
Phone
86-13886160811
Email
mayheng@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies

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