Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

Stopped early · Phase 1

Conditions studied: Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

In brief

RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of donor T cells may helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood stem cell transplant. Note: Only Phase I portion of study was performed. Due to slow accrual, study was closed before Phase II portion of study.

Key facts

Study ID

NCT00725062

Run by

Masonic Cancer Center, University of Minnesota

People needed

3

Starts

2008-06-01

Expected to finish

2010-04-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a high-risk hematologic malignancy, including any of the following:
• Acute lymphocytic leukemia
• Acute myelocytic leukemia
• Chronic myelogenous leukemia
• Myelodysplastic syndrome
• Non-Hodgkin lymphoma
• Multiple myeloma
• Meet eligibility criteria and co-enrolled in one of the following University of Minnesota protocols:
• MT2001-02 consisting of myeloablative prep (cyclophosphamide and total body irradiation) followed by HLA-identical sibling peripheral blood progenitor cells (PBPC) transplantation
• MT2001-10 consisting of nonmyeloablative prep (cyclophosphamide, fludarabine and total body irradiation) followed by HLA-identical sibling PBPC transplantation
• Voluntarily written informed consent
• Must have an HLA-identical sibling donor available, meeting the following criteria:
• 12 to 75 years of age, >40 kg body weight and in good health
• Matched to recipient for HLA-A, B,DRB1 identical sibling match to recipient
• Must be able and willing to have a separate apheresis collection performed on day -21 for the purposes of this study (in addition to the apheresis required for the transplant protocol)
• Human immunodeficiency virus nucleic acid testing (HIV-NAT) negative, Human T-lymphotropic virus 1 (HTLV-1), HTLV-2 negative, hepatitic B and C negative

You may not qualify if…

• Not pregnant or nursing

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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