Extracorporal Photopheresis Pilot Study (ECP)

Civil Hospices of Lyon

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hematological Malignancies

Treatments: Drug: methoxsalen; Procedure: Extracoporal Photopheresis (ECP)

Study type: Interventional

Funder types: Other

Identifiers

NCT00930566

2006.409

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Extracorporal Photopheresis

Experimental group

Treatment:

Procedure: Extracoporal Photopheresis (ECP)

Drug: methoxsalen