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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning; TP53; Myeloid Tumors
• Intervention / Treatment: Drug: Busulfan (BU); Drug: Cyclophosphamide (CY); Drug: Decitabine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Hematology,Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decitabine + BUCY; 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.	Drug: Busulfan (BU); Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Drug: Cyclophosphamide (CY); Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.; Drug: Decitabine; Decitabine was administered at 20mg/m2/day on days -14 and -10.
Active Comparator: BUCY; 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.	Drug: Busulfan (BU); Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Drug: Cyclophosphamide (CY); Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse rate	relapse rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	overall survival (OS)	1 year
disease-free survival (DFS)	disease-free survival (DFS)	1 year
transplant-related mortality (TRM)	transplant-related mortality (TRM)	1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Peking University People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Zhujiang Hospital; Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Decitabine; Busulfan
• Other Study ID Numbers: TP53+ Myeloid tumors

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No