Status:
UNKNOWN
Extracorporal Photopheresis Pilot Study
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 E...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00930566
Start Date
April 1 2009
End Date
September 1 2015
Last Update
April 24 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre de Santé - Etablissement Français du Sang (EFS)
Lyon, France, 69003
2
Hôpital Edouard Herriot, Service d'Hématologie
Lyon, France, 69003