CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

NCT00038818 | Terminated

• 1 other identifier: ID00-335
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient Response Rates of Acute or Chronic GVHD

  2 years

Study Arms (1)

CD8 DLI

EXPERIMENTAL

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

Biological: CD8 Depleted Donor Lymphocyte

Interventions

CD8 Depleted Donor Lymphocyte BIOLOGICAL

CD8 DLI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eligix: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid

Study Officials

• Richard Champlin, MD, BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2002
• First Posted: June 7, 2002
• Study Start: May 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

US (1)