Venetoclax and Decitabin Based Conditioning Regimen Followed With Post-HSCT Decitabin Maintenance Therapy in TP53 Mutant AML/MDS Patients

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

June 2, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Hematopoietic Stem Cell TransplantationTP53
Interventions
DRUG

VEN and DEC based conditioning regimen

"Patients with age\<50 years and HCT-CI\<3:~Haploidentical transplantation: AraC 2g/m2 d-10\~d-9, BU 0.8mg/kg q6h d-8\~-6, CTX 1.8g/m2 d-5\~d-4, Meccnu 250mg/m2 d-3, ATG 1.5mg/kg/d d-5\~-2, VEN 400mg/d d-15\~-9, DEC 20mg/m2 d-15\~-11; HLA-matched transplantation: BU 0.8mg/kg q6h d-7\~-4, CTX 60mg/kg d-3\~d-2, Meccnu 250mg/m2 d-1, VEN d-12\~-8, DEC 20mg/m2 d-12\~-6, and ATG for the unrelated donor type.~Patients with age\>50 years or HCT-CI≥3:~Flu 30mg/m2 d-10\~-5, BU 0.8mg/kg q6h d-7\~-5, Meccnu 250mg/m2 d-4, ATG 7.5mg/kg divided into d-4\~-1, VEN d-15\~-9, DEC 20mg/m2 d-15\~-11.~Note: if Voriconazole or Posaconazole is used to prevent or treat fungal infections, VEN should be 200mg/d for 7 consecutive days."

DRUG

DEC

"In the time window of 60-120 days after transplantation: DEC 5mg/m2/d for 5 consecutive days every 6 to 8 weeks with a total of 4 to 6 courses if there is no severe aGVHD (grade 3 or higher) and the donor chimerism rate of bone marrow blood (STR)\>95%.~If the MRD turns positive, DLI can be performed."

Trial Locations (1)

310006

RECRUITING

The First Hospital of Zhejiang Medical Colleage Zhejiang University, Hangzhou

All Listed Sponsors
lead

Zhejiang University

OTHER