Back to resultsAmifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
amifostine trihydrate
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring refractory anemia with excess blasts, refractory anemia, refractory anemia with ringed sideroblasts, de novo myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory cytopenia with multilineage dysplasia
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of myelodysplastic syndromes (MDS) One of the following subtypes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts Refractory cytopenia with multilineage dysplasia (RCMD) RCMD and ringed sideroblasts MDS, unclassified MDS associated with isolated del 5(q) De novo disease No treatment-induced MDS No juvenile myelomonocytic leukemia No Down syndrome, Fanconi's anemia, or other inherited forms of hypoplastic bone marrow failure PATIENT CHARACTERISTICS: Age 1 to 21 at original diagnosis Performance status Karnofsky 50-100% (patients > 16 years of age) Lansky 50-100% (patients 1 to 16 years of age) Life expectancy At least 8 weeks Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT < 2.5 times ULN Renal Radioisotope glomerular filtration rate ≥ 60 mL/min OR Creatinine clearance > 60 mL/min (based on Schwartz formula) Calcium normal Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Serum electrolytes normal Phosphorus normal Magnesium normal Glucose normal No other concurrent malignancy PRIOR CONCURRENT THERAPY: Biologic therapy More than 8 weeks since prior growth factors No concurrent growth factors No concurrent hematopoietic stem cell transplantation No concurrent immunomodulating agents Chemotherapy No prior amifostine No other concurrent anticancer chemotherapy Endocrine therapy No concurrent daily steroid therapy Radiotherapy Not specified Surgery Not specified Other No prior therapy for MDS
Sites / Locations
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Children's Hospital Central California
- Kaiser Permanente Medical Center - Oakland
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Miami Children's Hospital
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Winship Cancer Institute of Emory University
- Cancer Research Center of Hawaii
- Advocate Christ Medical Center
- Indiana University Cancer Center
- St. Vincent Indianapolis Hospital
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Kosair Children's Hospital
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- CancerCare of Maine at Eastern Maine Medial Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Spectrum Health Hospital - Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Breslin Cancer Center at Ingham Regional Medical Center
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Saint Peter's University Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- University of New Mexico Cancer Research and Treatment Center
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Maimonides Cancer Center at Maimonides Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- New York Medical College
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Tod Children's Hospital - Forum Health
- Oklahoma University Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Greenville Hospital System Cancer Center
- East Tennessee Children's Hospital
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Children's Hospital of Austin
- Medical City Dallas Hospital
- Cook Children's Medical Center - Fort Worth
- Baylor University Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Children's Hospital and Regional Medical Center - Seattle
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center
- Princess Margaret Hospital for Children
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
Outcomes
Primary Outcome Measures
Hematological effects (complete and partial response)
Safety and efficacy
Secondary Outcome Measures
Efficacy
Duration of progression-free remission
Effect of karyotypic abnormalities on survival
Effect of the number of cytopenias on survival
Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
Full Information
NCT ID
NCT00098683
First Posted
December 7, 2004
Last Updated
February 11, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00098683
Brief Title
Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
Official Title
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well amifostine works in treating young patients with newly diagnosed de novo myelodysplastic syndromes.
Detailed Description
OBJECTIVES:
Primary
Determine the hematologic effects of amifostine, in terms of, complete and partial response, in pediatric patients with newly diagnosed de novo myelodysplastic syndromes (MDS).
Determine the safety and efficacy of this drug in these patients.
Secondary
Determine the efficacy of this drug in preventing conversion of MDS to acute myeloid leukemia (AML) in terms of the proportion of patients who remain free of AML at the completion of study treatment.
Determine the duration of progression-free remission from MDS conversion to AML in patients treated with this drug.
Determine the effect of karyotypic abnormalities on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
Determine the effect of bone marrow blast count on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
Determine the effect of the number of cytopenias on survival in patients treated with this drug.
Correlate the duration of time from diagnosis of MDS until conversion to AML with survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive amifostine IV over 1-3 minutes on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease who are planning to undergo matched donor bone marrow or cord blood transplantation continue therapy until transplantation. Patients with stable or responding disease who are not undergoing transplantation may receive up to 4 additional courses of amifostine in the absence of disease progression or unacceptable toxicity.
Following completion of therapy with amifostine, patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 5-10 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Keywords
refractory anemia with excess blasts, refractory anemia, refractory anemia with ringed sideroblasts, de novo myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory cytopenia with multilineage dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Primary Outcome Measure Information:
Title
Hematological effects (complete and partial response)
Title
Safety and efficacy
Secondary Outcome Measure Information:
Title
Efficacy
Title
Duration of progression-free remission
Title
Effect of karyotypic abnormalities on survival
Title
Effect of the number of cytopenias on survival
Title
Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of myelodysplastic syndromes (MDS)
One of the following subtypes:
Refractory anemia (RA)
RA with ringed sideroblasts
RA with excess blasts
Refractory cytopenia with multilineage dysplasia (RCMD)
RCMD and ringed sideroblasts
MDS, unclassified
MDS associated with isolated del 5(q)
De novo disease
No treatment-induced MDS
No juvenile myelomonocytic leukemia
No Down syndrome, Fanconi's anemia, or other inherited forms of hypoplastic bone marrow failure
PATIENT CHARACTERISTICS:
Age
1 to 21 at original diagnosis
Performance status
Karnofsky 50-100% (patients > 16 years of age)
Lansky 50-100% (patients 1 to 16 years of age)
Life expectancy
At least 8 weeks
Hematopoietic
See Disease Characteristics
Hepatic
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT < 2.5 times ULN
Renal
Radioisotope glomerular filtration rate ≥ 60 mL/min OR
Creatinine clearance > 60 mL/min (based on Schwartz formula)
Calcium normal
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Serum electrolytes normal
Phosphorus normal
Magnesium normal
Glucose normal
No other concurrent malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
More than 8 weeks since prior growth factors
No concurrent growth factors
No concurrent hematopoietic stem cell transplantation
No concurrent immunomodulating agents
Chemotherapy
No prior amifostine
No other concurrent anticancer chemotherapy
Endocrine therapy
No concurrent daily steroid therapy
Radiotherapy
Not specified
Surgery
Not specified
Other
No prior therapy for MDS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad Mathew, MD
Organizational Affiliation
University of New Mexico Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert J. Arceci, MD, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
95813
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medial Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Spectrum Health Hospital - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Maimonides Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Tod Children's Hospital - Forum Health
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Greenville Hospital System Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Children's Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-9958
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
21681928
Citation
Mathew P, Gerbing R, Alonzo TA, Wallas T, Gong JZ, Jasty R, Jorstad DT, Raimondi SC, Chavez CM, Eisenberg NL, Hirsch B, Gamis A, Smith FO, Arceci RJ. A phase II study of amifostine in children with myelodysplastic syndrome: a report from the Children's Oncology Group study (AAML0121). Pediatr Blood Cancer. 2011 Dec 15;57(7):1230-2. doi: 10.1002/pbc.23164. Epub 2011 Jun 16.
Results Reference
result
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Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
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