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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00354120
Eligibility Criteria:
Inclusion Criteria:
* Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual)
* Group 2: patients \<= 65 yo suffering from lympho-proliferative diseases according the REAL classification:
* High-doses chemotherapy relapsed CLL (B and T)
* Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy
* Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Advanced (stage ≥ III A) or relapsed T lymphomas
* Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens
* Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy
* Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells.
Exclusion Criteria:
* Performance status \< 70% (Karnofsky)
* Left ventricular cardiac ejection fraction \< 40% or receiving treatment for heart failure
* DLCO pulmonary \< 40% or receiving continuous oxygen therapy
* Neuropathy (previous or at present)
* Pregnancy
* Patients with arterial hypertension not controlled with multi-pharmacological treatments
* HIV positive
* B-CLL with clear evidence of transformation into Richter syndrome
* Mycosis fungoides with clear evidence of transformation into blasts
* Hodgkin's disease refractory to chemotherapy
* Absence of informed consent
* Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00354120
Study Brief:
Protocol Section:
NCT00354120