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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00098683




Registration number
NCT00098683
Ethics application status
Date submitted
7/12/2004
Date registered
8/12/2004
Date last updated
13/02/2014

Titles & IDs
Public title
Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
Scientific title
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
Secondary ID [1] 0 0
CDR0000398140
Secondary ID [2] 0 0
AAML0121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes 0 0
Myelodysplastic/Myeloproliferative Neoplasms 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - amifostine trihydrate

Treatment: Drugs: amifostine trihydrate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hematological effects (complete and partial response)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Safety and efficacy
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Duration of progression-free remission
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Effect of karyotypic abnormalities on survival
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Effect of the number of cytopenias on survival
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
Timepoint [5] 0 0

Eligibility
Key inclusion 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
Minimum age
1 Year
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Puerto Rico
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Santurce

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00098683
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prasad Mathew, MD
Address 0 0
University of New Mexico Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries