Natural Killer (NK) Cell Transplantation for AML
Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia
1 other identifier
interventional
49
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedResults Posted
Study results publicly available
November 9, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 19, 2014
October 1, 2013
6.4 years
September 12, 2005
October 10, 2012
June 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 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.
Beginning at on therapy through 100 days post-transplant
Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 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.
Beginning at on therapy through 100 days post-transplant
Secondary Outcomes (8)
Duration of Engraftment of Natural Killer (NK) Cells
Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated
Percent of Peak NK Cell Chimerism
Days 2, 7, 14, 21 and 28 after NK cell transplantation
Percent of Detectable Donor NK Cells at Day 28
At 28 days
Day That Maximum NK Cell Engraftment Was Reached
Day 0 through Day 28 post NK cell transplantation
Number of KIR-mismatched NK Cells
Day 2 and day 14 post NK cell transplantation
- +3 more secondary outcomes
Study Arms (2)
Stratum 1
EXPERIMENTALStratum 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
EXPERIMENTALStratum 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.
Interventions
See Detailed Description section for additional details of treatment interventions.
See Detailed Description section for additional details of treatment interventions.
See Detailed Description section for additional details of treatment interventions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants who are pregnant
- Participants with inadequate renal, liver, or pulmonary functions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Rubnitz JE, Inaba H, Ribeiro RC, Pounds S, Rooney B, Bell T, Pui CH, Leung W. NKAML: a pilot study to determine the safety and feasibility of haploidentical natural killer cell transplantation in childhood acute myeloid leukemia. J Clin Oncol. 2010 Feb 20;28(6):955-9. doi: 10.1200/JCO.2009.24.4590. Epub 2010 Jan 19.
PMID: 20085940RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Rubnitz, MD
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey E. Rubnitz, M.D.
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2012
Study Completion
March 1, 2013
Last Updated
June 19, 2014
Results First Posted
November 9, 2012
Record last verified: 2013-10