Extracorporal Photopheresis Pilot Study

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Methoxsalen

Criteria

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

Exclusion Criteria:

• 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