Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Riverside Haematology Group
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Idarubicin; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed de novo or secondary acute myeloid leukemia (AML)

• Prior myelodysplasia allowed

• Refractory anemia with excess blasts (RAEB) OR

• RAEB in transformation

• No relapsed AML

• No chronic granulocytic leukemia in transformation

• No CNS disease

PATIENT CHARACTERISTICS:

Age:

• Over 55

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.5 times ULN

Cardiovascular:

• No severe or uncontrolled cardiac failure

Other:

• No serious medical, social, or psychological condition

• Not HIV 1 or 2 seropositive

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No plan for future autograft

Chemotherapy:

• No prior chemotherapy for myelodysplastic syndrome or AML

Endocrine therapy:

• Not specifed

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent aluminum or magnesium-based antacids