Clinical trial · Interventional
Interferon-α Prevents Leukemia Relapse of AML Patients After Transplantation
Interferon-α Prevents Leukemia Relapse of AML Patients Undergoing HLA-identical Allogeneic Hematopoietic Stem Cell Transplantation With Pretransplant MRD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): there was almost no patient would enroll in this study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Interferon-A-2B | — | UNRESOLVED | — |
| Prevention | — | UNRESOLVED | — |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interferon alpha group
- description
- 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.
- interventionNames
- Drug: Interferon-alpha
Primary outcomes (1)
- measure
- cumulative incidence of relapse
- timeFrame
- within the first year after transplantation
- description
- the cumulative incidence of relapse
Secondary outcomes (7)
- measure
- OS
- timeFrame
- within the first year after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available