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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534634
• Other study ID #: IFN-a+CAR-T
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2020
• Source: The First Affiliated Hospital of Soochow University
• Contact: xiaowen tang, Ph.D
• Phone: 1391353826
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Combination Product:
• IFN-a combined with CAR-T cell therapy
Adults: 14 daily intramuscular injections 300 million IU of Interferon-a for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m^2 of Interferon-a for a 28-day cycle. CAR T cell: (1-2)×10^7/kg, intravenously infusion.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	2 years
Secondary	Overall survival (OS)	time from enrollment to the date of death from any cause	2 years
Secondary	Leukemia-free survival (LFS)	time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause	2 years
Secondary	Cumulative incidence of relapse(CIR)	time from the date of achievement of a remission until the date of relapse	2 years
Secondary	the duration of CAR-T cells in patients	the time of CAR-T cells' persistence in blood and the copies of CAR-T cells	2 years
Secondary	Number of adverse events	adverse events are evaluated with CTCAE V5.0	2 years