Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT

Phase 4

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Interferon-alpha

• Registration Number: NCT02027064
• Lead Sponsor: Peking University People's Hospital

Brief Summary

molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.

Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.

the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• high risk t (8; 21) AML
• molecular relapse after allo-SCT

Exclusion Criteria

• active graft-versus-host disease
• uncontrolled severe infection
• organ function failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interferon	Interferon-alpha	-

Primary Outcome Measures

Name	Time	Method
relapse rate	participants will be followed for an expected average of 365 days	number of participants with morphologic relapse at one year

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China