Extracorporal Photopheresis Pilot Study (ECP)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Hematological Malignancies
• Intervention / Treatment: Drug: methoxsalen; Procedure: Extracoporal Photopheresis (ECP)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mauricette Michallet, Professor; Phone Number: +33472117402; Email: mauricette.michallet@chu-lyon.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: 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 Names: ECP kits : UVAR®XTS™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	TRM at 3 months for acute GVHD and at 1 year for chronic GVHD	at 3 months and 1 year
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Mauricette Michallet, Professor, Hospices Civils de Lyon; Principal Investigator: Olivier Hequet, MD, Etablissement francais du sang

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ANTICIPATED): September 1, 2015

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (ESTIMATE): June 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Allogeneic Hematopoietic Stem Cell Transplantation; Extracorporeal Photopheresis
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Photosensitizing Agents; Dermatologic Agents; Methoxsalen
• Other Study ID Numbers: 2006.409