Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT00930566
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00930566
Study Brief:
Protocol Section:
NCT00930566