Extracorporal Photopheresis Pilot Study

Hematological Malignancies Clinical Trial

— ECP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00930566
• Other study ID #: 2006.409
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 29, 2009
• Last updated: April 23, 2013
• Start date: April 2009
• Est. completion date: September 2015

Study information

• Verified date: April 2013
• Source: Hospices Civils de Lyon
• Contact: Mauricette Michallet, Professor
• Phone: +33472117402
• Email: mauricette.michallet[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hematological Malignancies

Intervention

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.

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.

Locations

Country	Name	City	State
France	Centre de Santé - Etablissement Français du Sang (EFS)	Lyon
France	Hôpital Edouard Herriot, Service d'Hématologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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