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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.


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Hematological Malignancies

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Description:

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

Outcome Time Frame:

Day 100

Safety Issue:

Yes

Principal Investigator

Mauricette Michallet, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2006.409

NCT ID:

NCT00930566

Start Date:

April 2009

Completion Date:

September 2015

Related Keywords:

  • Hematological Malignancies
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Extracorporeal Photopheresis
  • Neoplasms
  • Hematologic Neoplasms

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