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Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）

Primary Purpose

B-cell Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IFN-α combined with CAR-T cell therapy
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia focused on measuring IFN-α, CAR-T

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
  2. Age 12-65.
  3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
  4. Target on leukemia is >20% positive detected with flowcytometry.
  5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.

5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.

6.No other immunotherapy was received within 3 months.

Exclusion Criteria:

  1. Patients are pregnant or lactating.
  2. Patients with congenital immunodeficiency.
  3. Patients with central nervous system leukemia.
  4. Patients with uncontrolled active infection.
  5. Patients with active hepatitis B or hepatitis C infection.
  6. Patients with HIV infection.
  7. Patients with atrial or venous thrombosis or embolism.
  8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
  9. Other comorbidities that investigators considered not suitable for this study.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

IFN-α combined with CAR T-cells therapy

CAR T-cells therapy

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

Secondary Outcome Measures

Overall survival (OS)
time from enrollment to the date of death from any cause
Leukemia-free survival (LFS)
time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
the duration of CAR-T cells in patients
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Number of adverse events
adverse events are evaluated with CTCAE V5.0

Full Information

First Posted
August 25, 2020
Last Updated
August 28, 2020
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT04534634
Brief Title
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
Official Title
An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Detailed Description
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia
Keywords
IFN-α, CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
IFN-α combined with CAR T-cells therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
CAR T-cells therapy
Intervention Type
Combination Product
Intervention Name(s)
IFN-α combined with CAR-T cell therapy
Other Intervention Name(s)
CAR-T cell therapy
Intervention Description
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m^2 of Interferon-α for a 28-day cycle. CAR T cell: (1-2)×10^7/kg, intravenously infusion.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
time from enrollment to the date of death from any cause
Time Frame
2 years
Title
Leukemia-free survival (LFS)
Description
time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause
Time Frame
2 years
Title
Cumulative incidence of relapse(CIR)
Description
time from the date of achievement of a remission until the date of relapse
Time Frame
2 years
Title
the duration of CAR-T cells in patients
Description
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Time Frame
2 years
Title
Number of adverse events
Description
adverse events are evaluated with CTCAE V5.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed refractory and relapsed acute B-lymphoblastic leukemia. Age 12-65. Eastern Cooperative Oncology Group (ECOG) score 0-2. Target on leukemia is >20% positive detected with flowcytometry. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. 5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL. 6.No other immunotherapy was received within 3 months. Exclusion Criteria: Patients are pregnant or lactating. Patients with congenital immunodeficiency. Patients with central nervous system leukemia. Patients with uncontrolled active infection. Patients with active hepatitis B or hepatitis C infection. Patients with HIV infection. Patients with atrial or venous thrombosis or embolism. Patients with myo-infarction or severe arrythmia in the recent 6 months. Other comorbidities that investigators considered not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaowen tang, Ph.D
Phone
1391353826
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
depei wu, Ph.D
Phone
86-0512677801856
Email
drwudepei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaowen tang, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaowen tang, doctor
Phone
13913538266
Email
xwtang1020@163.com

12. IPD Sharing Statement

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Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）

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