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Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

A Phase II Trial of Venetoclax-Enhanced Reduced Intensity HLA-Mismatched Allogeneic Transplant for Ultra-High-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

NCT06337331•Northside Hospital, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Availability of a 4/8 - 6/8 HLA-matched related donor or a 7/8 HLA-matched unrelated donor
•Receiving first allogeneic transplant
•KPS \>/= 70%
•MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR
•AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH
•Less than 5% myeloblasts in the marrow pre-transplant

Exclusion Criteria

•Poor cardiac function defined as LVEF \<45%
•Poor pulmonary function defined as FEV1, FVC, or DLCO \<50% predicted
•Poor liver function defined as bilirubin \>/=2.5mg/dL, AST/ALT \>3xULN
•Poor renal function defined as creatinine \>/=2.0mg/dL or CrCl \<40mL/min
•Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
•Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant

Locations (1)

Caitlin Guzowski

Atlanta, Georgia, United States

Key Dates

Start Date

August 31, 2024

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2027

Last Updated

June 14, 2024

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Interventions

Venetoclax

DRUG

Decitabine

DRUG

Fludarabine

DRUG

Busulfan

DRUG

Total Body Irradiation

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias