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Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia


Phase 2
2 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia


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.


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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Natural Killer (NK) Cell Expansion

Outcome Description:

Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).

Outcome Time Frame:

Study Day 14

Safety Issue:

No

Principal Investigator

Jeffrey Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000450852

NCT ID:

NCT00274846

Start Date:

March 2005

Completion Date:

June 2008

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • secondary acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Masonic Cancer CenterMinneapolis, Minnesota  55455