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CompletedNCT00167167Updated Nov 29, 2017

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

An interventional study of Donor Lymphocyte Infusion in Leukemia, Myeloid, Chronic, AML and MDS, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
1 Year to 60 Years
Sex
All
01

Study 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.

Read the detailed description

We will collect immune cells or lymphocytes from the donor's blood using a cell separator. The blood lymphocytes will be given to the subjects through a catheter. If the subjects have no complications of the first course of infusions, we may decide to give them "lymphocytes" aa second time while subjects are in remission in an attempt to prevent their disease from relapsing. A bone marrow test will be taken prior to infusion of lymphocytes as part of the clinical evaluation to receive this treatment. After lymphocyte infusions, a bone marrow will be examined about every three months for the first year to monitor progress from this therapy.

02

Conditions studied

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

Keywords

  • Donor Lymphocyte Infusion
  • relapse
  • post-transplant
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 40 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    BMT patients

    All patients treated.

    Procedure: Donor Lymphocyte Infusion

Interventions

  • ProcedureDonor Lymphocyte Infusion

    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.

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

  1. Toxicity

    Time frame: during the infusion and immediately thereafter

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

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

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

    Time frame: ongoing

  4. Marrow Aplasia including duration, treatment and outcomes.

    Time frame: ongoing

07

Study locations

1 site
  • University of Minnesota Medical Center
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00167167
Lead sponsor
Masonic Cancer Center, University of Minnesota
First posted
Sep 14, 2005
Start date
Dec 1995
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Nov 29, 2017

Study contacts

Jeffrey Miller, MD
principal investigator · University of Minnesota Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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