Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT06337331
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    400mg/day PO Days -8 to -2
  • Decitabine — DRUG
    20mg/m2/day IV Days -7 to -3
  • Fludarabine — DRUG
    30mg/m2/day IV Days -7 to -3
  • Busulfan — DRUG
    3.2mg/kg/day IV Days -5 to -4
  • Total Body Irradiation — RADIATION
    200cGy Day -2

Study Details

Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.

Key Dates

Start date
Aug 31, 2024
Status verified
Jun 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant

Primary Outcome Measure

Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Caitlin GuzowskiAtlantaGeorgia30342-

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By research site
Caitlin Guzowski· Atlanta, GA

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