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Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation | Clinical Trials | Clareo Health

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Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation

Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS

NCT07214064•University Hospital Tuebingen

View on ClinicalTrials.gov

Summary

Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age between 18 and 75 years at the time of signing the Informed Consent
•2. Patient is fluent in German
•3. Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial related procedures
•4. Diagnosis of AML,MDS/AML (according to ICC 20226) or HRMDS (IPSS-R7 \>3.5 or IPSS-M8 \>0; according to ICC 20226 and IWG 20232)
•5. Myeloid neoplasm (AML, MDS/AML or HR-MDS according to ICC 20226) under control\* at time of screening, defined as one of the following:
•5.1. AML (ICC 20226):
•• Scheduled for alloHCT after prior Remission
•Induction ± Consolidation:
•* Achievement of at least MLFS\*\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR
•* Achievement of at least MLFS\*\* (according to ELN 20221 criteria) after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR
+28 more criteria

Exclusion Criteria

•1. APL (AML with t(15;17))
•2. MDS/MPN (ICC 20226)
•3. Karnofsky Performance Index \<60%
•4. Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation
•5. Presence of extramedullary myelosarcoma
•6. Disease Relapse after prior CRc
•7. History of allogeneic hematopoietic stem cell transplantation
•8. Significant active cardiac disease within 6 months prior to the start of study treatment, including:
•* New York Heart Association (NYHA) class III or IV congestive heart failure
•* Myocardial infarction
+24 more criteria

Locations (1)

University Hospital , Department of Internal Medicine II

Tübingen, Baden-Wurttemberg, Germany

Key Dates

Start Date

January 1, 2026

Primary Completion Date

August 1, 2027

Completion Date

December 1, 2027

Last Updated

October 9, 2025

Enrollment

ESTIMATED participants

Conditions

AML (Acute Myeloid Leukemia)MDS/AMLMDS (Myelodysplastic Syndrome)

Interventions

RIC regimen

DRUG

Contacts

Christoph Faul, Dr.

CONTACT

+49 7071 29-84087 Christoph.Faul@med.uni-tuebingen.de

Wolfgang Bethge, Prof. Dr.

CONTACT

+49 7071 29-83176 Wolfgang.Bethge@med.uni-tuebingen.de

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AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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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: October 9, 2025Data 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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Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

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