Clinical trial NCT00930566: Extracorporal Photopheresis Pilot Study
Official title: Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hematological Malignancies
Keywords: Allogeneic Hematopoietic Stem Cell Transplantation
Extracorporeal Photopheresis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Day 100
Secondary outcomes:
measure: Efficacy: decrease in incidence of acute GVHD and chronic GVHD
timeFrame: during 2 years
measure: Incidence of Infection (clinically et/or bacteriologically proved)
timeFrame: during 2 years
measure: Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]
timeFrame: during 2 years
measure: Transplant-related Mortality
timeFrame: at 3 months and 1 year
measure: Toxicity at Day 180 after HSC transplantation
timeFrame: Day 180
measure: Disease-free survival (DFS)
timeFrame: at 1 and 2 years
measure: progression-free survival (PFS)
timeFrame: at 1 and 2 years
measure: Overall survival (OS)
timeFrame: at 1 and 2 years
measure: cumulative incidence of relapse
timeFrame: at 1 and 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Santé - Etablissement Français du Sang (EFS)
city: Lyon
country: France
facility: Hôpital Edouard Herriot, Service d'Hématologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Mauricette Michallet, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Etablissement Français du Sang
name: Olivier Hequet, MD
role: PRINCIPAL_INVESTIGATOR
References: