Interferon-α Prevents Leukemia Relapse of AML Patients After Transplantation

• Status: Withdrawn
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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