Status:
UNKNOWN
Haplo-identical Transplantation in Patients With Myelofibrosis - A Phase 2 Prospective Multicentric Prospective Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The only curative treatment in patients with primary or secondary myelofibrosis is allogeneic hematopoietic stem cells (HSCT). It has been reported that intermediate and higher risk patients according...
Eligibility Criteria
Inclusion
- 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:
- constitutional symptoms: weight loss \> 10% in one year, fever (without infection), recurrent muscle, bone or join pains, extreme fatigue
- anemia with hemoglobin \< 10 gr/dL or red blood cell transfusion requirement
- thrombocytopenia \< 100 G/L
- peripheral blast count \> 1% at least found 2 times
- white blood cell count \> 25 G/L (before a cytoreductive treatment)
- 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
Exclusion
- Myelofibrosis transformed into acute leukemia
- 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
- Pregnant woman or breastfeeding
- Contraindications to treosulfan
- Hypersensitivity to the active substance
- Active non-controlled infectious disease
- Fanconi anaemia and other DNA breakage repair disorders
- Administration of live vaccine
- Contraindications or any circumstance that precludes the use of the drugs involved in the protocol (especially Thiotepa and Fludarabine)
Key Trial Info
Start Date :
January 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04728490
Start Date
January 30 2021
End Date
January 30 2024
Last Update
January 28 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.