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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00740467
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of any of the following hematological cancers with a poor prognosis:
* Acute myeloid leukemia meeting 1 of the following criteria:
* Third complete remission (CR3) or beyond
* CR2 after an early bone marrow relapse (\< 24 months)
* Refractory disease after ≥ 2 chemotherapy courses of induction therapy
* Acute lymphoblastic leukemia meeting 1 of the following criteria:
* CR3 after ≥ 1 bone marrow relapse
* CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy)
* Chronic myelogenous leukemia meeting the following criteria:
* Accelerated phase
* Second chronic phase
* No other treatment options
* Multiple myeloma meeting the following criteria:
* Failed conventional therapy (including autologous hematopoietic stem cell transplantation)
* No other treatment alternatives
* Chronic lymphocytic leukemia meeting the following criteria:
* Failed conventional therapy
* No other treatment alternatives
* Hodgkin lymphoma meeting the following criteria:
* Failed conventional therapy
* No other treatment alternatives
* Non-Hodgkin lymphoma meeting the following criteria:
* Failed conventional therapy
* No other treatment alternatives
* Not eligible for standard myeloablative allograft due to increased toxicity
* Healthy related donor available and meeting the following criteria:
* Brother, sister, father, mother, cousin, uncle, or aunt
* At least an identical HLA haplotype
* Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR)
* Different on ≤ 4 alleles on the other haplotype
* No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No contraindication to allogeneic transplantation, including any of the following:
* Cardiac systolic ejection fraction \< 40%
* DLCO level limiting use of fludarabine
* Creatinine clearance \< 30 mL/min
* Transaminases and/or bilirubin \> 3 times upper limit of normal (unless due to Gilbert disease or cancer)
* HIV seropositivity
* Human T-cell lymphotrophic virus type 1 seropositivity
* Uncontrolled bacterial, viral, or fungal infection
* No contraindication to any of the study drugs
* No prior or concurrent psychiatric illness
* No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent serious, uncontrolled condition
* No patients deprived of liberty or subject to legal protection
PRIOR CONCURRENT THERAPY:
* No participation in a study of allografts in the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00740467
Study Brief:
Protocol Section:
NCT00740467