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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00038818
Collaborator
Eligix (Other)
3
Enrollment
1
Location
1
Arm
19
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: CD8 Depleted Donor Lymphocyte
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Study Start Date :
May 1, 2001
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2002

Arms and Interventions

ArmIntervention/Treatment
Experimental: CD8 DLI

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

Biological: CD8 Depleted Donor Lymphocyte

Outcome Measures

Primary Outcome Measures

  1. Patient Response Rates of Acute or Chronic GVHD [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UT MD Anderson Cancer CenterHoustonTexasUnited States77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • Eligix

Investigators

  • Principal Investigator: Richard Champlin, MD, BS, UT MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038818
Other Study ID Numbers:
  • ID00-335
First Posted:
Jun 7, 2002
Last Update Posted:
Aug 23, 2012
Last Verified:
Aug 1, 2012

Study Results

No Results Posted as of Aug 23, 2012