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Prospective and multicentre evaluation of 3 different doses of IV busulfan associated with fludarabine and thymoglobuline in the conditioning of allogeneic stem cell transplantation (SCT) from a matched related or unrelated donor in patients with poor prognosis myeloïd malignancies
EU CTIS ID: 2024-516435-27-00
What this study is testing
To assess the 2-year progression free survival rates in patients with high-risk myeloid ma-lignancies following HSCT using different dose levels of IV Busulfan (BX3 and BX4) com-bined with fludarabine and thymoglobuline as conditioning therapy
- 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
- Patients with poor prognosis myeloid malignancies in particular : myelodysplasic syndrome, AML beyond CR1 regardless of the cytogenetic or molecular abnormalities or CR1 AML after double induction regardless of the cytogenetic or molecular abnormalities or CR1 AML with no criteria for favorable risk according to the ELN classification
- Adult patients aged ≥ 50 years up to 65 or < 50 years not eligible for myeloablative conditioning regimen based on TBI or double alkylating agent combinations
- Availability of a HLA identical sibling or matched unrelated donor (10/10)
- Affiliation to social security
- Written Informed Consent
You likely can't join if
- History of previous Allo-HSCT
- HIV positivity
- Signs of chronic active hepatitis B and/or C
- Evolutive psychiatric disease
- Concomitant neoplasic disease
- Pregnant or lactating woman or without contraception (for child bearing potential women)
See the full eligibility criteria
- Patients with poor prognosis myeloid malignancies in particular : myelodysplasic syndrome, AML beyond CR1 regardless of the cytogenetic or molecular abnormalities or CR1 AML after double induction regardless of the cytogenetic or molecular abnormalities or CR1 AML with no criteria for favorable risk according to the ELN classification
- Adult patients aged ≥ 50 years up to 65 or < 50 years not eligible for myeloablative conditioning regimen based on TBI or double alkylating agent combinations
- Availability of a HLA identical sibling or matched unrelated donor (10/10)
- Affiliation to social security
- Written Informed Consent
- History of previous Allo-HSCT
- HIV positivity
- Signs of chronic active hepatitis B and/or C
- Evolutive psychiatric disease
- Concomitant neoplasic disease
- Pregnant or lactating woman or without contraception (for child bearing potential women)
- Usual contra-indications for Allo-HSCT
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.
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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.