Extracorporal Photopheresis Pilot Study

NCT00930566 | Unknown Phase 1 DMC

• 1 other identifier: 2006.409
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematological Malignancies

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Extracorporeal Photopheresis

Outcome Measures

Primary Outcomes (1)

• 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.

  All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria

  Day 100

Secondary Outcomes (9)

• 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

• Toxicity at Day 180 after HSC transplantation

  Day 180

Study Arms (1)

Extracorporal Photopheresis

EXPERIMENTAL

Drug: methoxsalen; Procedure: Extracoporal Photopheresis (ECP)

Interventions

methoxsalen DRUG

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.

Also known as: UVADEX®

Extracorporal Photopheresis

Extracoporal Photopheresis (ECP) PROCEDURE

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.

Also known as: ECP kits : UVAR®XTS™

Extracorporal Photopheresis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Centre de Santé - Etablissement Français du Sang (EFS)

Lyon, 69003, France

ACTIVE NOT RECRUITING

Hôpital Edouard Herriot, Service d'Hématologie

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Methoxsalen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Mauricette Michallet, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Olivier Hequet, MD

  Etablissement Français du Sang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricette Michallet, Professor

CONTACT

+33472117402; mauricette.michallet@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2015
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

FR (2)