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Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

NCT05807932 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-05-01

No results posted yet for this study

Summary

This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)

Conditions

Interventions

DRUG

Venetoclax

Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment.

DRUG

Amsacrine

Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

DRUG

Ara-C

Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

DRUG

Tacrolimus

Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Sponsors & Collaborators

  • Koordinierungszentrum für Klinische Studien - Duesseldorf

    collaborator UNKNOWN

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Guido Kobbe, Prof. Dr. · Coordinating Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2026-01-31
Completion
2028-01-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT05807932 on ClinicalTrials.gov