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

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04534634
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 76
• Patients Per Site Per Month: 0.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
B-cell Acute Lymphoblastic Leukemia	Combination Product: IFN-α combined with CAR-T cell therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group IFN-α combined with CAR T-cells therapy	Combination Product: IFN-α combined with CAR-T cell therapy; 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.; Other Names: CAR-T cell therapy
No Intervention: Control group CAR T-cells therapy

Outcome Measures

Primary Outcome Measures

1. Overall response rate (ORR) [2 years]

   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

1. Overall survival (OS) [2 years]

   time from enrollment to the date of death from any cause

2. Leukemia-free survival (LFS) [2 years]

   time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause

3. Cumulative incidence of relapse(CIR) [2 years]

   time from the date of achievement of a remission until the date of relapse

4. the duration of CAR-T cells in patients [2 years]

   the time of CAR-T cells' persistence in blood and the copies of CAR-T cells

5. Number of adverse events [2 years]

   adverse events are evaluated with CTCAE V5.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University

Investigators

• Principal Investigator: xiaowen tang, Ph.D, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaowen Tang, Chief Physician, The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT04534634
• Other Study ID Numbers: IFN-α+CAR-T
• First Posted: Sep 1, 2020
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaowen Tang, Chief Physician, The First Affiliated Hospital of Soochow University: IFN-α, CAR-T
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid

Study Results

No Results Posted as of Sep 1, 2020