CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Inclusion 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