2024-513325-23-00招募中2 期
FIBRAPLO - Haplo-identical transplantation in patients with myleofibrosis : A phase 2 prospective multicentric prospective study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 19
- 主要终点
- The main criteria of judgement is disease- and rejection-free survival 12 months after HSCT.
研究概览
简要总结
The main objective is disease-free survival and without rejection one year after haplo-identical transplantation in patients with primary or secondary myelofibrosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- • 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
排除标准
- • 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
结局指标
主要结局
The main criteria of judgement is disease- and rejection-free survival 12 months after HSCT.
The main criteria of judgement is disease- and rejection-free survival 12 months after HSCT.
次要结局
- incidence of acute grade 2-4 and grade 3-4 GVHD according to the modified Glucksberg classification
- incidence of chronic GVHD (limited vs extensive) at 12 months according to the revised Seattle criteria
- neutrophil engraftment on day 60 post-transplantation, engraftment is defined as neutrophil count at 0.5G/L or higher for more than 3 consecutive days after transplantation, it should be confirmed by a donor chimerism
- latelet recovery: first day of platelet > 20G/L without transfusion the last 7 days assessed on day 100
- overall survival at 12 months
- on-relapse mortality at 12 months
- incidence of relapse/progression at 12 months
- incidence of rejection at 12 months
- infection incidence at 100 days, 12 months (annexe for infection)
- cytokine profile during transplantation (day-7 +/- 1 jour, J0 and day J7 +/- 1 jour )
- impact of genetic alterations on overall survival at 12 months and non-relapse mortality at 12 months
研究者
Dr. Marie ROBIN
Scientific
Assistance Publique Hopitaux De Paris
研究点 (19)
Loading locations...
相似试验
招募中
3 期
autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial2024-511235-10-00Klinikum der Universitaet Muenchen AöR832
招募中
2 期
Allogeneic hematopoietic cell transplantation from HLA-matched donor after Flu-Mel-PTCy versus Flu-Mel-ATG reduced-intensity conditioning: a phase II randomized study from the Belgian Hematology Society (BHS)2024-518568-11-00Centre Hospitalier Universitaire De Liege, Centre Hospitalier Universitaire De Liege114
招募中
3 期
Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)2024-514706-31-01Centre Oscar Lambret352
尚未招募
2 期
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.2024-516005-23-00Centre Hospitalier Regional Universitaire34
已完成
4 期
OPTIMIZE2024-516509-22-00Universitair Medisch Centrum Groningen381