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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00112593
Eligibility Criteria:
Inclusion Criteria:
* Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met:
* The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors
* Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant
* Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy
* CD4 count is allowed to be \> 100 cells/ul
* HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met:
* They have been treated with more than one regimen of HAART for a total of at least 6 months duration
* The viral load is \< 50 copies/ml plasma
* The CD4 count \< 100 cells/ul
* DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if more than one HLA-identical sibling is available, priority will be given to donors matched for cytomegalovirus (CMV) status, ABO titer, and sex
* Peripheral blood stem cells will be collected from donors greater than 12 years of age
* Bone marrow will be collected from donors less than 12 years of age
* DONOR: HLA phenotypically identical unrelated donor; match grades allowed:
* Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1
* Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1
Exclusion Criteria:
* Positive serology for toxoplasma gondii on treatment or with evidence of active infection
* Patients with other disease or organ dysfunction that would limit survival to less than 30 days
* Patients with medical history of noncompliance with HAART or medical therapy
* DONOR: Donors for whom medical or psychologic reasons would make donor procedure intolerable
* DONOR: Marrow donors who have increased anesthetic risk
* DONOR: Donors who are HIV positive
* DONOR: Age \> 75 years
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00112593
Study Brief:
Protocol Section:
NCT00112593