NCT03121079

Brief Summary

Allogeneic stem cell transplantation (SCT) remains a powerful therapeutic modality for patients with acute myeloid leukemia (AML).The superior clinical outcomes of allogeneic human SCT versus chemotherapy alone as post-remission treatment could be related to the graft-versus-leukemia (GVL) effects of recovered donor T cells. Our previous study investigated both the association of MRD status with transplant outcomes in haplo-SCT and matched sibling donor transplantation(MSDT)， and also possible differences in the transplant outcomes of patients with positive pre-MRD (as determined by MFC) who underwent haplo-SCT versus MSDT. It provided new evidence that unmanipulated haplo-SCT is superior to matched sibling donor transplantation in eradicating pre-transplantation MRD, indicating that unmanipulated haploidentical allografts have stronger GVL effects.As to the AML patients in standard-risk, who have a positive MRD before MSDT, whether these patients should be given any relapse prevention is the question to be answered in this study. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b following hematopoietic stem cell transplantation in patients with standard-risk AML can further reduce relapse rate and improve leukemia-free survival.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

April 14, 2017

Last Update Submit

September 21, 2020

Conditions

Interferon-A-2BRelapsePreventionHematopietic Stem Cell Transplantation

Keywords

Interferon-alphaRelapsepreventionhematopietic stem cell transplantationacute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of relapse

    the cumulative incidence of relapse

    within the first year after transplantation

Secondary Outcomes (7)

  • OS

    within the first year after transplantation

  • NRM

    within the first year after transplantation

  • DFS

    within the first year after transplantation

  • MRD

    within the first year after transplantation

  • acute GVHD

    within 100 days after transplantation

  • +2 more secondary outcomes

Other Outcomes (1)

  • Hematologic toxicity

    within the first year after transplantation

Study Arms (1)

Interferon alpha group

EXPERIMENTAL

The patients in arm will be receive interferon alpha injection (3 million U/time)twice a week, as the intervention since the third month after HLA-identical transplantation.

Drug: Interferon-alpha

Interventions

Interferon-alphaDRUG

patients in Interferon-alpha group will receive Interferon-alpha injection since the third month after transplantation for six months.

Interferon alpha group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • standard-risk AML in CR1/CR2
  • without t(9;22) and t(15;17)
  • receive HLA-identical transplantation
  • with positive MRD before transplantation (measured by flow cytometry)
  • CR within the first two months posttransplantation and MRD is negative
  • between 18-60 years

You may not qualify if:

  • uncontrolled GVHD
  • be in myelosuppression (WBC\<1.5x10\^9/L, ANC\<0.5×10\^9/L，PLT\<25×10\^9/L,HB\<65g/L)
  • severe infection
  • organ failure
  • the patients do not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

RecurrenceLeukemia, Myeloid, Acute

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Xiaojun Huang, Dr.

    Peking University Institute of Hematology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Peking University Institute of Hematology

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

May 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)