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Venetoclax as treatment of acute graft-versus-host disease
EU CTIS ID: 2025-520545-74-00
What this study is testing
To determine the maximum tolerated dose of Venetoclax
- 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
- Written informed consent, according to local guidelines, signed by the patients prior to any study related screening procedures are performed.
- Male or female patients
- ≥ 18 years old at the time of informed consent
- Able to swallow tablets
- Have undergone allo-HSCT from any donor source (matched unrelated, sibling, or haplo-identical donor) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm AND Platelet count > 20,000 /mm3 (7)
You likely can't join if
- Persons incapable of giving consent (permanently or temporarily)
- Patients with relapsed primary malignancy, or who have been treated for relapse after allo HSCT
- Known human immunodeficiency virus (HIV) infection
- Active tuberculosis infection that developed after allo HSCT
- Evidence of active viral disease including CMV, EBV, HHV -6, HBV, HCV, or BK virus.
- Prior treatment with venetoclax
See the full eligibility criteria
- Written informed consent, according to local guidelines, signed by the patients prior to any study related screening procedures are performed.
- Male or female patients
- ≥ 18 years old at the time of informed consent
- Able to swallow tablets
- Have undergone allo-HSCT from any donor source (matched unrelated, sibling, or haplo-identical donor) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm AND Platelet count > 20,000 /mm3 (7)
- Patients with newly clinically diagnosed aGVHD: aGVHD clinically diagnosed Grades II to IV as per standard criteria (13, 35, 36) occurring after allo HSCT requiring systemic immune suppressive therapy with prednisone 1-2 mg/kg bodyweight. Biopsy of involved organs with aGVHD is encouraged but not required for study screening. Evident myeloid and platelet engraftment (confirmed within 48h prior to study treatment start).
- Persons incapable of giving consent (permanently or temporarily)
- Patients with relapsed primary malignancy, or who have been treated for relapse after allo HSCT
- Known human immunodeficiency virus (HIV) infection
- Active tuberculosis infection that developed after allo HSCT
- Evidence of active viral disease including CMV, EBV, HHV -6, HBV, HCV, or BK virus.
- Prior treatment with venetoclax
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, 18-64 years, 65+ 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.