Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT

Phase 2

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Conditions; Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
• Interventions: Drug: Decitabine; Drug: Cyclophosphamide (CY); Drug: Busulfan (BU)

• Registration Number: NCT03596892
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Detailed Description

Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Last Update Submitted: 2018-07-13
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24
• Primary Completion: 2021-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• MLL+ acute leukemia undergoing allo-HSCT
• 14-65 years

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUCY	Cyclophosphamide (CY)	For MLL+ acute leukemia undergoing allo-HSCT，BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
Decitabine + BUCY	Cyclophosphamide (CY)	For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
Decitabine + BUCY	Busulfan (BU)	For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
BUCY	Busulfan (BU)	For MLL+ acute leukemia undergoing allo-HSCT，BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
Decitabine + BUCY	Decitabine	For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.

Primary Outcome Measures

Name	Time	Method
relapse rate	2 year

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	2 year
disease-free survival (DFS)	2 year
transplant-related mortality (TRM)	2 year

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China