Extracorporal Photopheresis Pilot Study
Phase 1
- Conditions
- Hematological Malignancies
- Interventions
- Procedure: Extracoporal Photopheresis (ECP)
- Registration Number
- NCT00930566
- Lead Sponsor
- Hospices Civils de Lyon
- 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 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Extracorporal Photopheresis Extracoporal Photopheresis (ECP) - Extracorporal Photopheresis methoxsalen -
- Primary Outcome Measures
Name Time Method Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor. Day 100 All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
- Secondary Outcome Measures
Name Time Method cumulative incidence of relapse at 1 and 2 years Efficacy: decrease in incidence of acute GVHD and chronic GVHD during 2 years Incidence of Infection (clinically et/or bacteriologically proved) during 2 years Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)] during 2 years Transplant-related Mortality at 3 months and 1 year TRM at 3 months for acute GVHD and at 1 year for chronic GVHD
Toxicity at Day 180 after HSC transplantation Day 180 Disease-free survival (DFS) at 1 and 2 years progression-free survival (PFS) at 1 and 2 years Overall survival (OS) at 1 and 2 years
Trial Locations
- Locations (2)
Centre de Santé - Etablissement Français du Sang (EFS)
🇫🇷Lyon, France
Hôpital Edouard Herriot, Service d'Hématologie
🇫🇷Lyon, France