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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT00096161
Eligibility Criteria:
Inclusion Criteria:
* Patients having received a preceding allogeneic transplantation from either a human leukocyte antigen (HLA)-matched related or unrelated donor are eligible for this protocol
* Related donor: HLA genotypically identical at least at one haplotype and may be phenotypically or genotypically identical at the allele level at HLA A, B, C, DRB1, and DQB1
* Unrelated donor who are prospectively:
* Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR
* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
* Patients with less than 50% donor CD3 peripheral blood chimerism on two separate, consecutive evaluations; the two evaluations must be at least 14 days apart OR patients with absolute decreases of donor CD3 peripheral blood chimerism of \>= 20% if the second test shows \< 50% donor CD3 cells; the two evaluations must be at least 14 days apart
* Patients with evidence of disease are only eligible if the disease is stable (or persistent) in comparison to the status prior to transplantation
* Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day
* Patients must have persistent donor CD3 cells (\>= 5% donor CD3 cells by a deoxyribonucleic acid \[DNA\]-based assay that compares the profile of amplified fragment length polymorphisms \[ampFLP\] \[or fluorescent in situ hybridization (FISH) studies or variable number of tandem repeats (VNTR)\])
* DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the following criteria apply for the DLI product:
* DONOR: Original donor of hematopoietic cell transplantation
* DONOR: Donor must give consent to leukapheresis
* DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
* DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional guidelines for apheresis)
Exclusion Criteria:
* Current grade II to IV acute GVHD or extensive chronic GVHD
* Karnofsky score \< 50%
* Pediatric criteria
* Lansky play-performance score \< 40
* Evidence of relapse or progression of disease after transplantation
* Prior recipient of cord blood
* DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
* DONOR: Pregnancy
* DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection
* DONOR: Recent immunization may require a delay
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00096161
Study Brief:
Protocol Section:
NCT00096161