Clinical trial · Interventional
Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
NCT00098683CI-TRIAL-00013757completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Hematological effects (complete and partial response)
- measure
- Safety and efficacy
Secondary outcomes (5)
- measure
- Efficacy
- measure
- Duration of progression-free remission
- measure
- Effect of karyotypic abnormalities on survival
- measure
- Effect of the number of cytopenias on survival
- measure
- Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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 MDSReferences
Publications (1)
- RESULTMathew 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. PMID 21681928