Skip to content

Compare the safety of Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Compare the safety of Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002810
Enrollment
Unknown
Registered
2012-09-22
Start date
2010-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Acute Myeloid Leukemia

Interventions

treatment group:amifostine+IA
control:IA

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 Years and older; 2. Both two genders; 3. Newly diagnosed patient with acute myeloid leukemia (AML) types M0-M2, M4-M7; 4. Histologically proven by bone marrow aspirate and biopsy requirement may be waived for patients with overt leukemia in the peripheral blood; 5. Evaluable disease; PATIENT CHARACTERISTICS: Age: 18 and over; Performance status: Karnofsky60-100%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: (1) No preexisting severe organ dysfunction; (2) No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study; (3) Not pregnant or nursing; (4) 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.

Exclusion criteria

Exclusion criteria: not applicable

Design outcomes

Primary

MeasureTime frame
nonhematologic side effects;

Secondary

MeasureTime frame
hypotension;

Contacts

Public ContactJin LU
jin1lu@sina.com+86 13311491805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026