Natural Killer (NK) Cell Transplantation for AML

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187096
First received: September 12, 2005
Last updated: November 6, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.


Condition Intervention
Acute Myeloid Leukemia
Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
Procedure: Natural Killer Cell Infusion
Device: CliniMACS System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant [ Time Frame: Beginning at on therapy through 100 days post-transplant ] [ Designated as safety issue: Yes ]
    Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.

  • Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant [ Time Frame: Beginning at on therapy through 100 days post-transplant ] [ Designated as safety issue: Yes ]
    Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.


Enrollment: 49
Study Start Date: September 2005
Study Completion Date: March 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratum 1

Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0

Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
See Detailed Description section for additional details of treatment interventions.
Procedure: Natural Killer Cell Infusion
See Detailed Description section for additional details of treatment interventions.
Device: CliniMACS System
See Detailed Description section for additional details of treatment interventions.
Experimental: Stratum 2

Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.

Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
See Detailed Description section for additional details of treatment interventions.
Procedure: Natural Killer Cell Infusion
See Detailed Description section for additional details of treatment interventions.
Device: CliniMACS System
See Detailed Description section for additional details of treatment interventions.

Detailed Description:

Natural killer (NK) cells extracted from a [parental] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.

Details of Treatment Plan:

Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0

Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.

For patients who have received prior SCT, the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor.

Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three times per week for two weeks (6 doses) starting on the evening of day -1.

NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will be infused on day 0.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease.
  • Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery
  • Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT.

Exclusion Criteria:

  • Participants who are pregnant
  • Participants with inadequate renal, liver, or pulmonary functions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187096

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Jeffrey E. Rubnitz, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187096     History of Changes
Other Study ID Numbers: NKAML
Study First Received: September 12, 2005
Results First Received: October 10, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Leukemia
Myeloid
Acute

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Fludarabine monophosphate
Fludarabine
Clofarabine
Etoposide
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014