Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia

NCT00167167 | Completed

• 3 other identifiers: 9510M10277MT1995-241996LS146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study our hypothesis is that infusion of donor lymphocyte immune cells from the subject's bone marrow donor will activate the subject's immune system to attack their cancer.

Conditions

Leukemia, Myeloid, Chronic; AML; MDS; Leukemia, Lymphocytic, Acute

Keywords

Donor Lymphocyte Infusion; relapse; post-transplant

Outcome Measures

Primary Outcomes (1)

• Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated.

  before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions

Secondary Outcomes (4)

• Toxicity

  during the infusion and immediately thereafter

• All data concerning acute toxicity including allergic reactions, capillary leak syndrome, and other Grade 4 toxicity will be collected and tabulated.

  during the infusion,immediately thereafter, and at 1 month, 3 months, 6 months, 9 months, 1 year and yearly.

• Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated.

  ongoing

• Marrow Aplasia including duration, treatment and outcomes.

  ongoing

Study Arms (1)

BMT patients

EXPERIMENTAL

All patients treated.

Procedure: Donor Lymphocyte Infusion

Interventions

Donor Lymphocyte Infusion PROCEDURE

Certain immune cells in your donor's blood called "lymphocytes" have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's "lymphocytes" in the hope of activating the recipient's immune system to attack cancer.

BMT patients

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with CML, AML, MDS or ALL relapsed after related or unrelated donor allogeneic marrow transplantation.
• Patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor DNA by RFLP or cytogenetics.
• Patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria.
• CML patients must have cytogenetic evidence of relapse or if Ph negative to start, obvious evidence of relapse other than minimal residual disease.
• Patients must have \<30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion.
• Patients with \>30% blasts can become eligible for donor lymphocytes after reinduction with any standard therapy regimen.
• Patients with AML, MDS or ALL achieving a CR with standard therapy regimens are eligible for this protocol.
• Patients who relapse with their initial disease or develop a second malignancy after related or unrelated donor allogeneic marrow transplantation with other initial diagnoses (such as but not limited to CLL, lymphoma, myeloma, juvenile CML, sarcoma, breast cancer) may also be included in this protocol. Patients will be eligible with or without other adjunct chemotherapy or radiation therapy. Post-transplant lymphomas (often referred to as EBV-associated lymphomas) will be eligible for donor leukocyte infusions on this protocol. Treatment with donor leukocytes under this protocol is restricted to malignant diseases only. Graft failure or relapse of non-malignant disorders is excluded from receiving donor leukocyte infusions on this protocol. Autologous transplant patients who relapse are not eligible for this protocol. Patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers).

You may not qualify if:

• Patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
• Patients with \>30% marrow blasts at the time of therapy will be ineligible.
• Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD.
• CML patients in complete cytogenetic remission who are bcr/abl positive by PCR only are not eligible.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

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; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jeffrey Miller, MD

  University of Minnesota Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: December 1, 1995
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)