IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

• Status: Completed
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangzhou First People's Hospital; Peking University People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Sun Yat-sen University; Third Affiliated Hospital, Sun Yat-Sen University; Zhujiang Hospital
• Treatments: Busulfan; Cyclophosphamide; Idarubicin

Criteria

Inclusion Criteria:

• Intermediate-risk AML

• Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens

• With negative MRD before mobilization and collect of peripheral blood stem cells

• Without HLA-matched donors (related and unrelated)

• Refusal of haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)

• Patients with any conditions not suitable for the trial (investigators' decision)