Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies

Sponsor
Xianmin Song, MD
Study ID
NCT05583175
Phase
PHASE2
Status
Unknown

Conditions

  • Hematopoietic Stem Cell Transplantation
  • Leukemia, Myeloid, Acute
  • MDS
  • Myeloid Malignancy

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax plus RIC — DRUG
    Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d\~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d\~-2d (5d), Cytarabine: 1g/m2/d, - 6d\~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d\~-5d (2d), TBI: 3 Gray, - 1d.

Study Details

This study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients.

Key Dates

Start date
Nov 1, 2022
Status verified
Nov 2023
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax plus RIC
    Administration with oral Venetoclax plus RIC regimen for allo-HSCT in the elderly patients with myeloid malignancies.

Primary Outcome Measure

PFS [ Time Frame: 1- year PFS ]

Central Contacts

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