Clinical trial NCT00038818: CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
Official title: CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Myelogenous Leukemia
Multiple Myeloma
Non Hodgkin's Lymphoma
Hodgkin's Disease
Chronic Lymphocytic Leukemia
Keywords: CML
MM
NHL
HD
CLL
CD8 Depleted
Donor Lymphocyte
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Eligix
First posted: 2002-06-07
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Response Rates of Acute or Chronic GVHD
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Richard Champlin, MD, BS
role: PRINCIPAL_INVESTIGATOR
References: