Clinical trial · Interventional
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.
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 |
|---|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia (AML) * M0-M2, M4-M7 * Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood) * M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid * Evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * Ejection fraction at least 50% * Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration Other: * No preexisting severe organ dysfunction * No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study * Not pregnant or nursing * Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior cytotoxic therapy for AML * No prior amifostine * At least 1 month since chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since radiotherapy Surgery: * Not specified
References
Publications (0)
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