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FIBRAPLO - Haplo-identical transplantation in patients with myleofibrosis
EU CTIS ID: 2024-513325-23-00
What this study is testing
The main objective is disease-free survival and without rejection one year after haplo-identical transplantation in patients with primary or secondary myelofibrosis.
- 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 aged between 18 and 70 years
- Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia Vera proven by marrow biopsy
- The myelofibrosis should combine at least 2 of the following criteria: o constitutional symptoms: weight loss > 10% in one year, fever (without infection), recurrent muscle, bone or join pains, extreme fatigue o anemia with hemoglobin < 10 gr/dL or red blood cell transfusion requirement o thrombocytopenia < 100 G/L o peripheral blast count > 1% at least found 2 times o white blood cell count > 25 G/L (before a cytoreductive treatment) o Karyotype: +8, -7/7q-, i(17q), -5, 5q-, 12p-, inv(3), 11q23
- Performance status according to ECOG at 0, 1 or 2
- With health insurance coverage
- Having signed a written informed consent
You likely can't join if
- Myelofibrosis transformed into acute leukemia
- Pregnant woman or breastfeeding
- Contraindications to treosulfan o Hypersensitivity to the active substance o Active non-controlled infectious disease o Fanconi anaemia and other DNA breakage repair disorders o Administration of live vaccine
- Contraindications or any circumstance that precludes the use of the drugs involved in the protocol (especially Thiotepa and Fludarabine)
- Poor performance status with ECOG 3 or more
- Cardiac failure with EF < or = 50% currently or in the past (even if corrected after treatment)
See the full eligibility criteria
- Patients aged between 18 and 70 years
- Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia Vera proven by marrow biopsy
- The myelofibrosis should combine at least 2 of the following criteria: o constitutional symptoms: weight loss > 10% in one year, fever (without infection), recurrent muscle, bone or join pains, extreme fatigue o anemia with hemoglobin < 10 gr/dL or red blood cell transfusion requirement o thrombocytopenia < 100 G/L o peripheral blast count > 1% at least found 2 times o white blood cell count > 25 G/L (before a cytoreductive treatment) o Karyotype: +8, -7/7q-, i(17q), -5, 5q-, 12p-, inv(3), 11q23
- Performance status according to ECOG at 0, 1 or 2
- With health insurance coverage
- Having signed a written informed consent
- Women agreed to take nomegestrol acetate as contraception during and up to 6 months after treatment by treosulfan
- Men agreed not to conceive child during and up to 6 months after treatment by treosulfan
- Myelofibrosis transformed into acute leukemia
- Pregnant woman or breastfeeding
- Contraindications to treosulfan o Hypersensitivity to the active substance o Active non-controlled infectious disease o Fanconi anaemia and other DNA breakage repair disorders o Administration of live vaccine
- Contraindications or any circumstance that precludes the use of the drugs involved in the protocol (especially Thiotepa and Fludarabine)
- Poor performance status with ECOG 3 or more
- Cardiac failure with EF < or = 50% currently or in the past (even if corrected after treatment)
- Renal failure with creatininemia > 130 µmol/L or clearance < 50ml/min
- Respiratory function altered with vital capacity < 70% or forced expired volume < 70%
- Biological significant liver abnormalities; ASAT or ALAT> 2 x normal range, bilirubin > 1,5 x normal range
- HLA matched donor available
- Tutorship or curatorship
- Unwilling or unable to comply with the protocol
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.