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

NCT06337331 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-06-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Venetoclax

400mg/day PO Days -8 to -2

DRUG

Decitabine

20mg/m2/day IV Days -7 to -3

DRUG

Fludarabine

30mg/m2/day IV Days -7 to -3

DRUG

Busulfan

3.2mg/kg/day IV Days -5 to -4

RADIATION

Total Body Irradiation

200cGy Day -2

Sponsors & Collaborators

  • Northside Hospital, Inc.

    lead OTHER

Principal Investigators

  • Scott Solomon, MD · Northside Hospital/BMTGA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT06337331 on ClinicalTrials.gov