Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05807932

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

Led by Heinrich-Heine University, Duesseldorf · Updated on 2024-05-01

38

Participants Needed

6

Research Sites

239 weeks

Total Duration

On this page

Sponsors

H

Heinrich-Heine University, Duesseldorf

Lead Sponsor

K

Koordinierungszentrum für Klinische Studien - Duesseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must voluntarily sign informed consent approved by an independent ethics committee before any study procedures
  • Diagnosed with MDS, CMML, or sAML with marrow blast count over 5% and/or high-risk genetic features per WHO 2016 classification
  • Untreated except for oral Hydroxyurea or up to 2 courses of Azacytidine, Decitabine alone or combined with Venetoclax
  • Have a well-matched (10 out of 10) related or unrelated donor
  • Age 18 years or older
  • Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) of 3 or less (except prior solid tumor treatment)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at study entry
  • No active, uncontrolled infection at inclusion
  • Able to follow study visit schedule and protocol requirements
  • Female of childbearing potential must understand embryo-fetal risks of Venetoclax, agree to pregnancy testing, avoid pregnancy during treatment and for 1 month after, use effective contraception including barrier methods, and notify the study doctor if pregnancy risk occurs
  • Males must agree to use condoms from study day 1 through 30 days after last dose and notify investigator if partner pregnancy occurs
Not Eligible

You will not qualify if you...

  • Secondary acute myeloid leukemia with known FLT3 mutation (ITD or TKD)
  • Marrow blast count greater than 30% at screening
  • Peripheral white blood count over 20,000 per microliter despite Hydroxyurea treatment
  • Previous cytotoxic therapy exceeding oral Hydroxyurea or more than 2 courses of Azacytidine, Decitabine, or low dose Ara-C alone or with Venetoclax
  • Prior allogeneic blood stem cell transplantation
  • Symptomatic central nervous system involvement with MDS, CMML, or sAML
  • Serious medical condition, lab abnormality, or psychiatric illness preventing informed consent
  • Pregnant or lactating females
  • Refusal to use safe contraceptive methods during study
  • Cardiac history including congestive heart failure (NYHA class >2), ejection fraction less than 40%, or chronic stable angina
  • Lung function with FEV1 less than 50% or DLCO less than 50% corrected for hemoglobin and/or volume
  • Impaired kidney function with GFR less than 45 ml/min
  • Liver impairment with AST or ALT 3 times upper limit of normal or total bilirubin 1.5 times upper limit unless due to Gilbert's syndrome or non-hepatic cause, or alkaline phosphatase 3 times upper limit
  • Known allergy to Venetoclax, Fludarabine, Amsacrine, Ara-C, or Treosulfan
  • Concurrent use of other anti-cancer treatments except Hydroxyurea and up to 2 courses of Azacytidine or Decitabine
  • Positive for HIV or replicating hepatitis A, B, C, or E
  • Prior malignancy other than MDS, CMML, or sAML unless disease-free for 2 or more years
  • Participation in another study with ongoing unlicensed investigational product use within 28 days or less than 5 half-lives before enrollment
  • Use of steroid therapy for anti-cancer intent or moderate/strong CYP3A inhibitors or inducers within 7 days prior to study drug
  • Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to study drug
  • Dependency on investigator or employment by sponsor or investigator
  • Held in an institution by legal or official order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Universitätsklinikum Aachen - Med. Klinik IV

Aachen, North Rhine-Westphalia, Germany, 52074

Actively Recruiting

2

Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und Klinische Immunologie

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

3

Universitätsklinikum Köln Klinik I für Innere Medizin

Cologne, Germany, 50937

Actively Recruiting

4

Universitätsklinikum Frankfurt Medizinische Klinik II

Frankfurt, Germany, 60590

Actively Recruiting

5

Universitätsklinikum Jena - Klinik für Innere Medizin II

Jena, Germany, 07747

Actively Recruiting

6

Klinikum rechts der Isar der TU München Klinik und Poliklinik für Innere Medizin III

München, Germany, 81675

Actively Recruiting

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Research Team

G

Guido Kobbe, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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