ECP: Extracorporal Photopheresis Pilot Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extracorporal Photopheresis
|
Drug: methoxsalen
UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®.
In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula :
Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag.
After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
Other Names:
Procedure: Extracoporal Photopheresis (ECP)
In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button.
After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- cumulative incidence of relapse [at 1 and 2 years]
Eligibility Criteria
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.
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or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
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CML and MPS in blastic phase achieving CR,
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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).
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MDS patients without prior chemotherapy
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HLA identical sibling donor
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Performans status < or = 2
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Patients member of a social security company
Exclusion Criteria:
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Age < 18 years or > 65 years
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Pregnant or lactating females
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Known HIV positivity
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Active infectious hepatitis, type A, B or C
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Performance status > 2 according to WHO
-
Left ventricular ejection fraction < 40% and Alveolus-capillary diffusion < 50%
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Uncontrollable hypertension with medical therapy
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Creatinine clearance < 60 ml/min
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Hypersensitivity or allergy to psoralen (methoxsalen)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Santé - Etablissement Français du Sang (EFS) | Lyon | France | 69003 | |
| 2 | Hôpital Edouard Herriot, Service d'Hématologie | Lyon | France | 69003 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Mauricette Michallet, Professor, Hospices Civils de Lyon
- Principal Investigator: Olivier Hequet, MD, Etablissement Français du Sang
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2006.409