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Extracorporal Photopheresis Pilot Study (ECP)

Primary Purpose

Hematological Malignancies

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

methoxsalen

Extracoporal Photopheresis (ECP)

About this trial

This is an interventional prevention trial for Hematological Malignancies focused on measuring Allogeneic Hematopoietic Stem Cell Transplantation, Extracorporeal Photopheresis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre de Santé - Etablissement Français du Sang (EFS)
Hôpital Edouard Herriot, Service d'HématologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extracorporal Photopheresis

Arm Description

Outcomes

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.

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

Incidence of Infection (clinically et/or bacteriologically proved)

Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]

Transplant-related Mortality

TRM at 3 months for acute GVHD and at 1 year for chronic GVHD

Toxicity at Day 180 after HSC transplantation

Disease-free survival (DFS)

progression-free survival (PFS)

Overall survival (OS)

cumulative incidence of relapse

Full Information

NCT ID

NCT00930566

First Posted

June 29, 2009

Last Updated

April 23, 2013

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00930566

Brief Title

Extracorporal Photopheresis Pilot Study

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Malignancies

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation, Extracorporeal Photopheresis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Extracorporal Photopheresis

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

methoxsalen

Other Intervention Name(s)

UVADEX®

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Extracoporal Photopheresis (ECP)

Other Intervention Name(s)

ECP kits : UVAR®XTS™

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

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

Time Frame

Day 100

Secondary Outcome Measure Information:

Title

Efficacy: decrease in incidence of acute GVHD and chronic GVHD

Time Frame

during 2 years

Title

Incidence of Infection (clinically et/or bacteriologically proved)

Time Frame

during 2 years

Title

Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]

Time Frame

during 2 years

Title

Transplant-related Mortality

Description

TRM at 3 months for acute GVHD and at 1 year for chronic GVHD

Time Frame

at 3 months and 1 year

Title

Toxicity at Day 180 after HSC transplantation

Time Frame

Day 180

Title

Disease-free survival (DFS)

Time Frame

at 1 and 2 years

Title

progression-free survival (PFS)

Time Frame

at 1 and 2 years

Title

Overall survival (OS)

Time Frame

at 1 and 2 years

Title

cumulative incidence of relapse

Time Frame

at 1 and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mauricette Michallet, Professor

Phone

+33472117402

mauricette.michallet@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauricette Michallet, Professor

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Olivier Hequet, MD

Organizational Affiliation

Etablissement Français du Sang

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de Santé - Etablissement Français du Sang (EFS)

City

Lyon

ZIP/Postal Code

69003

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Hôpital Edouard Herriot, Service d'Hématologie

City

Lyon

ZIP/Postal Code

69003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aline Praire

Phone

+33472117396

aline.praire@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Mauricette Michallet, Professor

12. IPD Sharing Statement

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Extracorporal Photopheresis Pilot Study

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