Informations générales (source: ClinicalTrials.gov)
Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation. (ECP)
Interventional
Phase 1/Phase 2
Hospices Civils de Lyon (Voir sur ClinicalTrials)
avril 2009
septembre 2015
29 juin 2024
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson]
according to the following schedule:
Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week
the first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre de Santé - Etablissement Français du Sang (EFS) - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Edouard Herriot, Service d'Hématologie - 69003 - Lyon - France | Aline Praire | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients ≥ 18 years and < or = 65 years with an hematological malignancy indicated
for an allogeneic transplantation after reduced intensity conditioning :
- due to the age : for patients between 55 and 65 years.
- or for patients between 18 and 55 years of age presenting a risk of increased
toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
- CML and MPS in blastic phase achieving CR,
- MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30%
or on first line if high risk,
- NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high
risk criteria are defined by : LAM 7, leukocytes>30000/mm3, cytogenetic
abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and
inv 3q,
- ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic
abnormalities: 11q23, t(9,22); t(1,19); t(4,11).
- MDS patients without prior chemotherapy
- HLA identical sibling donor
- Performans status < or = 2
- Patients member of a social security company
- Patients ≥ 18 years and < or = 65 years with an hematological malignancy indicated
for an allogeneic transplantation after reduced intensity conditioning :
- due to the age : for patients between 55 and 65 years.
- or for patients between 18 and 55 years of age presenting a risk of increased
toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
- CML and MPS in blastic phase achieving CR,
- MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30%
or on first line if high risk,
- NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high
risk criteria are defined by : LAM 7, leukocytes>30000/mm3, cytogenetic
abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and
inv 3q,
- ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic
abnormalities: 11q23, t(9,22); t(1,19); t(4,11).
- MDS patients without prior chemotherapy
- HLA identical sibling donor
- Performans status < or = 2
- Patients member of a social security company
- Age < 18 years or > 65 years
- Pregnant or lactating females
- Known HIV positivity
- Active infectious hepatitis, type A, B or C
- Performance status > 2 according to WHO
- Left ventricular ejection fraction < 40% and Alveolus-capillary diffusion < 50%
- Uncontrollable hypertension with medical therapy
- Creatinine clearance < 60 ml/min
- Hypersensitivity or allergy to psoralen (methoxsalen)
- Disease associated with a photosensitivity
- Hypersensitivity or allergy to both heparin and citrate products
- Contra-indication to Busulfan, Fludarabine, SAT or methotrexate
- Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid