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Completed

NCT Number: NCT00187096

Natural Killer (NK) Cell Transplantation for AML

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2

Drug

See Detailed Description section for additional details of treatment interventions.

Natural Killer Cell Infusion

Procedure

See Detailed Description section for additional details of treatment interventions.

CliniMACS System

Device

See Detailed Description section for additional details of treatment interventions.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Secondary outcomes

  1. Duration of Engraftment of Natural Killer (NK) Cells

    Time frame: Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated

    NK cell engraftment defined as NK cell chimerism in recipients.

  2. Percent of Peak NK Cell Chimerism

    Time frame: Days 2, 7, 14, 21 and 28 after NK cell transplantation

    The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion.

  3. Percent of Detectable Donor NK Cells at Day 28

    Time frame: At 28 days

    The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants.

  4. Day That Maximum NK Cell Engraftment Was Reached

    Time frame: Day 0 through Day 28 post NK cell transplantation

    The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients

  5. Number of KIR-mismatched NK Cells

    Time frame: Day 2 and day 14 post NK cell transplantation

    Number of KIR-mismatched donor NK cells in recipients' blood at day 2 and day 14 post NK cell infusion.

  6. Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)

    Time frame: Days 2, 7, 14, 21, and 28 after NK cell transplantation

    NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells.

  7. Relapse-free Survival

    Time frame: Up to 2 years post NK cell transplantation

    For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk.

  8. Overall Survival

    Time frame: Up to 2 years post NK cell transplantation

    Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.

    The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.

    The confidence interval for Arm 2b was determined by log hazard method.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia

Important dates

Study start
2005
Primary completion
2012
Study completion
2013
First posted
Sep 16, 2005
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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