Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Disease, Multiple Myeloma, Non Hodgkin's Lymphoma
Conditions
Keywords
CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte
Brief summary
Primary Objectives: To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD). Secondary Objectives: * To evaluate safety and treatment related mortality after CD8 depleted DLI. * To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. * To evaluate the incidence and timing of pancytopenia following DLI. * To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). * To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. * To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
Interventions
BIOLOGICALCD8 Depleted Donor Lymphocyte
Sponsors
Eligix
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Response Rates of Acute or Chronic GVHD | 2 years |
Countries
United States
Outcome results
None listed