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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 (Vestal)
EU CTIS ID: 2025-521372-62-00
What this study is testing
Treatment-Related Mortality at day 28 after alloHCT
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 75 years at the time of signing the Informed Consent
- Availability of a suitable donor
- Documented diffusion lung capacity for carbon monoxide (DLCO) >40% (adjusted for hemoglobin, if available) and FEV1/FVC >50%
- Left ventricular ejection fraction (LVEF) ≥40%
- GFR (CKD-EPI) ≥ 30 ml/min/1,73 m2
- Bilirubin≤ 3x ULN and AST ≤ 5x ULN
You likely can't join if
- APL (AML with t(15;17))
- GFR (CKD-EPI) < 30 ml/min/1,73 m2
- Bilirubin> 3x ULN or AST > 5x ULN
- Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.
- Active viral infection, including hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial. An infection controlled with an approved antiviral treatment is allowed
- Presence of Proven, Probable or Possible Invasive Fungal Disease (IFD) as defined by EORTC/MSG 20209 Definitions (please consult Appendix).
See the full eligibility criteria
Who can join
- Age between 18 and 75 years at the time of signing the Informed Consent
- Availability of a suitable donor
- Documented diffusion lung capacity for carbon monoxide (DLCO) >40% (adjusted for hemoglobin, if available) and FEV1/FVC >50%
- Left ventricular ejection fraction (LVEF) ≥40%
- GFR (CKD-EPI) ≥ 30 ml/min/1,73 m2
- Bilirubin≤ 3x ULN and AST ≤ 5x ULN
- Thoracic imaging (either X-ray or computed tomography (CT)) without evidence of active infection or second malignancy
- Absence of an active, clinically uncontrolled infection
- Subject (male or female) is willing to use highly effective methods during treatment and for 6 months (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). Female participants using homonal contraceptives should use a barrier method as well
- Absence of pregnancy confirmed by a highly sensitive pregnancy test not older than 3 days at time of screening (only FCBP).
- Subject agrees not to share medication
- Patient is fluent in German
- Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial relatred procedures
- Diagnosis of AML,MDS/AML (according to ICC 20226) or HR- MDS (IPSS-R7 >3.5 or IPSS-M8 >0; according to ICC 20226 and IWG 20232)
- Myeloid neoplasm (AML, MDS/AML or higher-risk MDS according to ICC 20226 and IWG 20232) under control* at time of screening
- Eligiblity for alloHCT according to a board of experienced haematologist
- Karnofsky Performance Index ≥60%
- Planned alloHCT with Peripheral Blood Stem Cells (PBS
- nfusion of allogeneic stem cells schedulded between day 14 and day 28 after Screening
What rules you out
- APL (AML with t(15;17))
- GFR (CKD-EPI) < 30 ml/min/1,73 m2
- Bilirubin> 3x ULN or AST > 5x ULN
- Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.
- Active viral infection, including hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial. An infection controlled with an approved antiviral treatment is allowed
- Presence of Proven, Probable or Possible Invasive Fungal Disease (IFD) as defined by EORTC/MSG 20209 Definitions (please consult Appendix).
- Serologies suggestive of recent (<6 months) infection or reactivation with/of Toxoplasma gondii (based on IgG, IgM and Avidity) or of infection with Treponema pallidum (based on TPPA).
- Any clinically uncontrolled infection (bacterial or unknown pathogen), defined as persisting or recurring fever or rising levels of CRP (≥10 mg/dl) despite intravenous antibacterial or antifungal therapy (initiated or escalated at least 72h hours ago).
- mmediate life‐threatening, severe complications of leukemia such as uncontrolled bleeding and/or disseminated intravascular coagulation
- Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.
- Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at <30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed: • Basal or squamous cell carcinoma of the skin; • Carcinoma in situ of the cervix; • Carcinoma in situ of the breast; • Incidental histologic finding of prostate cancer
- MDS/MPN (ICC 20226)
- Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patients, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy)
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- Women during pregnancy and lactation
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- Participation in other trials interfering with the endpoint of this study. Prior trial participation is permitted, provided that treatment with the investigational medicinal product has been completed at least 4 days prior to screening for this trial (at least 10 days before study treatment)
- Karnofsky Performance Index <60%
- Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation
- Presence of extramedullary myelosarcoma
- Disease Relapse after prior CRc (see Appendix for Definition
- History of allogeneic hematopoietic stem cell transplantation
- Significant active cardiac disease within 6 months prior to the start of study treatmen
- Documented diffusion lung capacity for carbon monoxide (DLCO) ≤40% (adjusted for hemoglobin, if available) and FEV1/FVC ≤50%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.