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Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02

Phase 2
2 Years
Not Enrolling
Leukemia, Myelogenous, Acute

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Trial Information

Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02

Patients achieving a complete remission and neutrophil recovery (ANC > 500) for at least 4
weeks will be considered for allogeneic transplant to prolong remission (independent of this

All patients, including those who go on to transplant, will be followed to determine disease
free survival, treatment related mortality, and time to relapse.

Inclusion Criteria:

- ≥ 2 years of age

- Meets one of the following disease criteria:

- Primary acute myelogenous leukemia (AML) induction failure: no complete
remission (CR) after 2 or more induction attempts

- Relapsed acute myelogenous leukemia (AML): not in CR after 1 or more cycles of
standard re-induction therapy. For patients > 60 years of age the 1 cycle of
standard chemotherapy is not required if either of the following criteria is

- relapse within 6 months of last chemotherapy

- blast count < 30% within 10 days of starting protocol therapy

- Secondary AML from myelodysplastic syndrome (MDS)

- AML relapsed > 2 months after transplant who do not have the option of donor
lymphocyte infusions (e.g. recipients of autologous or umbilical cord blood
[UCB] transplants) Patients with prior central nervous system (CNS) involvement
are eligible provided that it has been treated and CSF is clear for at least 2
weeks or magnetic resonance imaging (MRI) stable prior to enrollment. CNS
therapy (chemotherapy or radiation) should continue as medically indicated
during the study treatment.

- Available related HLA-haploidentical donor (3-5 of 6 HLA-A, B and C)

- Karnofsky Performance Status > 50% or Lansky Play score > 50

- Adequate organ function defined as:

- Creatinine: ≤ 2.0 mg/dL (for pediatric patients - ClCr > 50 ml/min or age
adjusted Cr)

- Hepatic: Liver function tests (LFT's) < 5 x upper limit of institutional normal

- Pulmonary Function: oxygen saturation ≥ 90% on room air and pulmonary function
>50% corrected Diffusion lung capacity for carbon monoxide (DLCO) and Forced
expiratory volume in one second (FEV1) Oxygen saturation [>92%] can be used in
child where pulmonary function tests (PFT's) cannot be obtained. (Testing
required only if symptomatic or prior known impairment.)

- Cardiac Function: Ejection fraction (EF) ≥ 40%, no uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities

- Able to be off prednisone or other immunosuppressive medications for at least 3 days
prior to natural killer (NK) cell infusion (excluding denileukin diftitox pre-meds)

- Women of child bearing potential must have a negative pregnancy test within 14 days
prior to study registration and agree to use adequate birth control during study

- Voluntary written consent

Exclusion Criteria:

- Bi-phenotypic acute leukemia

- Transplant < 60 days prior to study enrollment

- New or progressive pulmonary infiltrates on screening chest x-ray or chest computated
tomography (CT) scan that has not been evaluated with bronchoscopy, if feasible.
Infiltrates attributed to infection must be stable/improving (with associated
clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or
documented fungal infections). Surgical resection waives any waiting requirements.

- Uncontrolled bacterial or viral infections - chronic asymptomatic viral hepatitis is

- Pleural effusion large enough to be detectable on chest x-ray

- Known hypersensitivity to any of the study agents used

- Received investigational drugs within the 14 days before enrollment

- Known active CNS involvement

Type of Study:


Study Design:

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

Outcome Measure:

Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion

Outcome Description:

The primary objective of this study is to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion will be defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion.

Outcome Time Frame:

Day 14

Safety Issue:


Principal Investigator

Jeffrey S. Miller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

December 2012

Related Keywords:

  • Leukemia, Myelogenous, Acute
  • acute myelogenous leukemia
  • primary acute myelogenous leukemia
  • secondary acute myelogenous leukemia
  • relapsed acute myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455