Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT

Sponsors

Lead sponsor: Nanfang Hospital of Southern Medical University

Collaborator: Peking University People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital

Source Nanfang Hospital of Southern Medical University
Brief Summary

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. 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 TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Detailed Description

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for TP53+ myeloid tumors 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 TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Overall Status Recruiting
Start Date October 2019
Completion Date September 2023
Primary Completion Date September 2022
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
relapse rate 1 year
Secondary Outcome
Measure Time Frame
overall survival (OS) 1 year
disease-free survival (DFS) 1 year
transplant-related mortality (TRM) 1 year
Enrollment 196
Condition
Intervention

Intervention type: Drug

Intervention name: Decitabine

Description: Decitabine was administered at 20mg/m2/day on days -14 and -10.

Arm group label: Decitabine + BUCY

Intervention type: Drug

Intervention name: Busulfan (BU)

Description: Busulfan was administered at 3.2 mg/kg/day on days −7 to −4.

Intervention type: Drug

Intervention name: Cyclophosphamide (CY)

Description: Cyclophosphamide was administered at 60 mg/kg/day on days −3 to −2.

Eligibility

Criteria:

Inclusion Criteria:

- TP53+ Myeloid tumors 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)

Gender: All

Minimum age: 14 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Qifa Liu Principal Investigator Nanfang Hospital of Southern Medical University
Overall Contact

Last name: Qifa Liu

Phone: 020-61641611

Email: [email protected]

Location
facility status contact investigator Department of Hematology,Nanfang Hospital, Southern Medical University Li Xuan +86-020-61641613 [email protected] Qifa Liu Principal Investigator
Location Countries

China

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Nanfang Hospital of Southern Medical University

Investigator full name: Qifa Liu

Investigator title: Professor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Decitabine + BUCY

Arm group type: Experimental

Description: For TP53+ myeloid tumors 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.

Arm group label: BUCY

Arm group type: Active Comparator

Description: For TP53+ myeloid tumors 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov