Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia
NCT ID: NCT00553202
Last Updated: 2020-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2008-01-31
2020-03-31
Brief Summary
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PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting leukemia. Bone marrow donors can be selected based on the type of NK cells they have, specifically the killer immunoglobulin receptor (KIR) type. This study provides information on KIR type from potential donors, which can be used in selecting the bone marrow donor. This phase II trial of unrelated donor stem cell transplant in patients with high risk AML (monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of the patients and potential donors will be available to the treating transplant physician at the time of donor selection.
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Detailed Description
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* To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor (URD) and umbilical cord blood (UCB) hematopoietic cell transplantation (HCT) in young patients with acute myeloid leukemia with monosomy 7, -5/5q-, high FLT3 internal tandem duplication allelic ratio (High-FLT3-ITD AR), or refractory or relapsed acute myelogenous leukemia.
* To correlate the relationships between factors affecting NK receptor status and clinical events.
* To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML.
* To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients.
OUTLINE: This is a multicenter study.
* Preparative regimen: Patients receive 1 of the following regimens:
* Hematopoietic stem cell transplantation (SCT): Patients receive busulfan IV every 6 hours on days -9 to -6, high-dose cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1, and methylprednisolone IV on days -3 to -1.
* Umbilical cord blood (UCB) transplantation: Conditioning regimen, infusion procedures, and post-transplant immunoprophylaxis for patients with an UCB donor are according to institutional guidelines and standards.
* Allogeneic hematopoietic stem cell transplantation (SCT) or umbilical cord blood (UCB) transplant: Patients undergo allogeneic SCT or UCB transplant on day 0.
* Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50, followed by a taper until week 24. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the study objectives.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy and allogeneic SCT)
Patients receive busulfan IV every 6 hours on days -9 to -6, high-dose cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1, and methylprednisolone IV on days -3 to -1.
Patients undergo allogeneic hematopoietic stem cell transplantation (SCT) or allogeneic bone marrow transplantation (BMT) on day 0.
Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50, followed by a taper until week 24. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the pharmacological study objectives
anti-thymocyte globulin
Given IV
busulfan
Given IV
cyclophosphamide
Given IV
cyclosporine
Given IV or orally
methotrexate
Given IV
methylprednisolone
Given IV
tacrolimus
Given IV
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
allogeneic bone marrow transplantation
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
Undergo allogeneic hematopoietic SCT
Interventions
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anti-thymocyte globulin
Given IV
busulfan
Given IV
cyclophosphamide
Given IV
cyclosporine
Given IV or orally
methotrexate
Given IV
methylprednisolone
Given IV
tacrolimus
Given IV
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
allogeneic bone marrow transplantation
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
Undergo allogeneic hematopoietic SCT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recipients of unrelated marrow or cord blood are eligible for this study
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) (for patients over 16 years of age) or Lansky PS (for patients 16 and under) 50-100%
* Total bilirubin ≤ 2 mg/dL
* SGOT (AST) or SGPT (ALT) ≤ 2.5 times upper limit of normal
* DLCO ≥ 50% OR a normal chest x-ray and pulse oximetry in patients who are unable to undergo pulmonary function tests
* Shortening fraction ≥ 27% by ECHO
* Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min OR creatinine adjusted according to age
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with proven or suspected bacterial sepsis, pneumonia, or meningitis are eligible provided appropriate therapeutic measures have been initiated to control the presumed or proven infection, and systemic signs are not life-threatening
* No evidence or presence of a fungal infection within the past 30 days
PRIOR CONCURRENT THERAPY:
* Prior chemotherapy, radiotherapy or any antileukemic therapy allowed provided patients meet 1 of the following criteria:
* Received initial treatment for relapsed AML
* Patients with primary induction failure or relapse who have already received initial therapy and who may have gone on to have additional therapy prior to receiving protocol stipulated therapy on AAML05P1
* No treatment for fungal infection within the past 30 days
* Concurrent radiotherapy to localized painful lesions allowed
* No other concurrent cancer chemotherapy or immunomodulating agents
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Stella M. Davies, MBBS, PhD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Central California
Madera, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's - Dayton
Dayton, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
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Other Identifiers
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COG-AAML05P1
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00321
Identifier Type: REGISTRY
Identifier Source: secondary_id
AAML05P1
Identifier Type: -
Identifier Source: org_study_id
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