NCT04534634

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

4.3 years

First QC Date

August 25, 2020

Last Update Submit

August 28, 2020

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

IFN-α, CAR-T

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Overall survival (OS)

    2 years

  • Leukemia-free survival (LFS)

    2 years

  • Cumulative incidence of relapse(CIR)

    2 years

  • the duration of CAR-T cells in patients

    2 years

  • Number of adverse events

    2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

IFN-α combined with CAR T-cells therapy

Combination Product: IFN-α combined with CAR-T cell therapy

Control group

NO INTERVENTION

CAR T-cells therapy

Interventions

IFN-α combined with CAR-T cell therapyCOMBINATION_PRODUCT

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.

Also known as: CAR-T cell therapy
Experimental group

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
  • No other immunotherapy was received within 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • xiaowen tang, Ph.D

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaowen tang, Ph.D

CONTACT

1391353826xwtang1020@163.com

depei wu, Ph.D

CONTACT

86-0512677801856drwudepei@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 1, 2020

Study Start

April 1, 2019

Primary Completion

July 31, 2023

Study Completion

July 31, 2025

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

CN(1)