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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Interferon-alpha

Study type: Interventional

Funder types: Other

Identifiers

NCT02027064

PUPH IRB [2013](38)

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

interferon

Experimental group

Treatment:

Drug: Interferon-alpha