Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Leukemia

In brief

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) 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. PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.

Key facts

Study ID

NCT00274846

Run by

Masonic Cancer Center, University of Minnesota

People needed

21

Starts

2005-03-01

Expected to finish

2008-06-01

Last updated by the study team

2017-12-28

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
• Primary refractory disease (no complete response [CR] after ≥ 2 induction therapies)
• Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy
• Secondary AML from myelodysplastic syndromes
• Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants)
• Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib
• Over 60 years of age with relapse within 6 months after completion of last chemotherapy
• Over 60 years of age with blast count < 30% within 10 days before study entry
• Related HLA-haploidentical natural killer cell donor available
• No severe organ damage (by clinical or laboratory assessment)
• Performance status 50-100%
• No evidence of active infection on chest X-ray
• No active fungal infection

You may not qualify if…

• Active central nervous system (CNS) leukemia
• Pleural effusions large enough to be detectable by chest x-ray
• Pregnant or nursing (positive pregnancy test)
• Fertile patients must use effective contraception
• Less than 60 days since prior transplant
• Less than 3 days since prior prednisone
• Less than 3 days since other prior immunosuppressive medication

Where it is running

• Masonic Cancer Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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