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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT00038818
Eligibility Criteria:
* Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (\>20% donor cell within three months of study entry)
* Expected survival \>4 weeks
* CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation
1. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
2. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate \>10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
* CML patients with accelerated phase or blast crisis following allogeneic transplantation
* Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:
1. MM- patients with a rising M-protein is detectable at 180 days post-transplant
2. NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
3. CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
* Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
* Patient's original donor must be available for lymphocyte donation
* There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (\<16 mg/d) without evidence of active GVHD are also eligible.
* Patients must have a Zubrod PS\<2 (see appendix 7), Cr\<2.5, bilirubin \<3, and transaminases (SGPT, SGOT) \<4x normal
* Patient must be able to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00038818
Study Brief:
Protocol Section:
NCT00038818