Extracorporal Photopheresis Pilot Study (ECP)

This study is currently recruiting participants.
Verified April 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00930566
First received: June 29, 2009
Last updated: April 23, 2013
Last verified: April 2013
  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:


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™

  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 April 22, 2014