NCT02185261

Brief Summary

This study aimed to evaluate the efficacy of interferon α among patients undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute leukemia and many other hematological malignancies. However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.The persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen patients with a high risk of relapse to provide timely intervention and prevent post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients with MRD-positive after transplantation. The study hypothesis: Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can reduce relapse rate.

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
81

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable leukemia

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

First Submitted

Initial submission to the registry

February 10, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

7 years

First QC Date

February 10, 2014

Last Update Submit

June 6, 2018

Conditions

Leukemia

Keywords

RelapseMinimal residual diseaseGraft-versus-host diseaseAcute leukemiaInterferon Alfa-2b

Outcome Measures

Primary Outcomes (1)

  • relapse rate

    number of participants with morphologic relapse at one year

    participants will be followed for an expected average of 1 year

Secondary Outcomes (1)

  • The immunologic impact of subcutaneous interferon α-2b

    participants will be followed for an expected average of 1 year

Study Arms (1)

interferon Alfa-2b group

EXPERIMENTAL

Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b

Drug: Interferon Alfa-2b

Interventions

Interferon Alfa-2bDRUG

Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Also known as: INF α-2b
interferon Alfa-2b group

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual disease positive after hematopoietic stem cell transplantation

You may not qualify if:

  • Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology,Beijing

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (5)

  • Shen MZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Zhao XS, Qin YZ, Chang YJ, Liu KY, Huang XJ, Mo XD. Preemptive Interferon-alpha Therapy Could Protect Against Relapse and Improve Survival of Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation: Long-Term Results of Two Registry Studies. Front Immunol. 2022 Jan 28;13:757002. doi: 10.3389/fimmu.2022.757002. eCollection 2022.

    PMID: 35154096DERIVED

  • Liu S, Luo X, Zhang X, Xu L, Wang Y, Yan C, Chen H, Chen Y, Han W, Wang F, Wang J, Liu K, Huang X, Mo X. Preemptive interferon-alpha treatment could protect against relapse and improve long-term survival of ALL patients after allo-HSCT. Sci Rep. 2020 Nov 19;10(1):20148. doi: 10.1038/s41598-020-77186-9.

    PMID: 33214615DERIVED

  • Chang YJ, Wang Y, Xu LP, Zhang XH, Chen H, Chen YH, Wang FR, Wei-Han, Sun YQ, Yan CH, Tang FF, Mo XD, Liu YR, Liu KY, Huang XJ. Haploidentical donor is preferred over matched sibling donor for pre-transplantation MRD positive ALL: a phase 3 genetically randomized study. J Hematol Oncol. 2020 Mar 30;13(1):27. doi: 10.1186/s13045-020-00860-y.

    PMID: 32228710DERIVED

  • Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.

    PMID: 32103499DERIVED

  • Mo XD, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ. IFN-alpha Is Effective for Treatment of Minimal Residual Disease in Patients with Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation: Results of a Registry Study. Biol Blood Marrow Transplant. 2017 Aug;23(8):1303-1310. doi: 10.1016/j.bbmt.2017.04.023. Epub 2017 Apr 27.

    PMID: 28457953DERIVED

MeSH Terms

Conditions

LeukemiaRecurrenceNeoplasm, ResidualGraft vs Host Disease

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Xiao-Jun Huang, MD

    Peking University Institute of Hematology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Mo, MD

CONTACT

mxd453@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peking University Institute of Hematology

Study Record Dates

First Submitted

February 10, 2014

First Posted

July 9, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

CN(1)