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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00038818
• Other study ID #: ID00-335
• Status: Terminated
• Phase: N/A
• First received: June 5, 2002
• Last updated: August 22, 2012
• Start date: May 2001
• Est. completion date: December 2002

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non Hodgkin's Lymphoma

Intervention

Biological:
• CD8 Depleted Donor Lymphocyte

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Eligix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Response Rates of Acute or Chronic GVHD		2 years	No

External Links

•   UT MD Anderson Cancer Center website