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

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Conditions

Leukemia

Treatments

Biological: aldesleukin

Drug: fludarabine phosphate

Drug: cyclophosphamide

Procedure: in vitro treated peripheral blood stem cell transplantation

Biological: therapeutic allogeneic lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT00274846

UMN-2004LS073 (Other Identifier)

UMN-MT2004-25 (Other Identifier)

CDR0000450852

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with relapsed acute myeloid leukemia.

Secondary

Determine the response rate, in terms of complete remission, in patients treated with this regimen.
Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients treated with this regimen.
Determine the overall and progression-free survival of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Induction therapy: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on day -5 or on days -5 and -4.
Allogeneic natural killer (NK) cell-enriched peripheral blood stem cell transplantation: Patients receive allogeneic NK cell-enriched peripheral blood stem cells IV over 15-60 minutes on day 0. Patients also receive interleukin-2 subcutaneously beginning on day 0 and continuing 3 times a week for up to 2 weeks.

After completion of study treatment, patients are followed periodically for 3 months.

Enrollment

21 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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