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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning; Myeloid Tumors; TP53

Treatments: Drug: Cyclophosphamide (CY); Drug: Busulfan (BU); Drug: Decitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04123392

TP53+ Myeloid tumors

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Decitabine + BUCY

Experimental group

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.

Treatment:

Drug: Cyclophosphamide (CY)

Drug: Decitabine

Drug: Busulfan (BU)

BUCY

Active Comparator group

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.

Treatment:

Drug: Cyclophosphamide (CY)

Drug: Busulfan (BU)