Extracorporal Photopheresis Pilot Study - Full Text View

Purpose

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	Intervention	Phase
Hematological Malignancies	Drug: methoxsalen Procedure: Extracoporal Photopheresis (ECP)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Methoxsalen

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

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. [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: during 2 years ] [ Designated as safety issue: No ]
Incidence of Infection (clinically et/or bacteriologically proved) [ Time Frame: during 2 years ] [ Designated as safety issue: Yes ]
Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)] [ Time Frame: during 2 years ] [ Designated as safety issue: No ]
Transplant-related Mortality [ Time Frame: at 3 months and 1 year ] [ Designated as safety issue: No ]
TRM at 3 months for acute GVHD and at 1 year for chronic GVHD
Toxicity at Day 180 after HSC transplantation [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]
Disease-free survival (DFS) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
progression-free survival (PFS) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
cumulative incidence of relapse [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2015
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: UVADEX® 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 Name: ECP kits : UVAR®XTS™

Arms

Assigned Interventions

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 Name: UVADEX®

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 Name: ECP kits : UVAR®XTS™

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930566

Contacts

Contact: Mauricette Michallet, Professor

+33472117402

mauricette.michallet@chu-lyon.fr

Locations

France
Hôpital Edouard Herriot, Service d'Hématologie	Recruiting
Lyon, France, 69003
Contact: Aline Praire +33472117396 aline.praire@chu-lyon.fr
Principal Investigator: Mauricette Michallet, Professor
Centre de Santé - Etablissement Français du Sang (EFS)	Active, not recruiting
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

More Information

No publications provided

Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00930566 History of Changes
Other Study ID Numbers:	2006.409
Study First Received:	June 29, 2009
Last Updated:	April 23, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:

Allogeneic Hematopoietic Stem Cell Transplantation
Extracorporeal Photopheresis

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Methoxsalen
Photosensitizing Agents

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

Extracorporal Photopheresis Pilot Study (ECP)