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

N

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)

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)

Trial contacts and locations

1

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Central trial contact

Qifa Liu

Data sourced from clinicaltrials.gov

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