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

NCT05528354 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-09-06

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness and safety of Venetoclax and Decitabin based conditioning regimen followed with post-HSCT Decitabin maintenance therapy in TP53 mutant AML/MDS Patients.

Conditions

  • Hematopoietic Stem Cell Transplantation
  • TP53

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.

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528354 on ClinicalTrials.gov