Overview

Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia

Status:
Completed
Trial end date:
2004-12-01
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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy with filgrastim and/or tretinoin is more effective than combination chemotherapy alone for acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy with filgrastim and/or tretinoin to see how well they work compared to combination chemotherapy alone in treating patients with acute myeloid leukemia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical Research Council
Treatments:
Cytarabine
Daunorubicin
Etoposide
Fludarabine
Fludarabine phosphate
Lenograstim
Tretinoin
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia (AML) including de novo or secondary AML, or a
preexisting myelodysplastic syndrome

- Overt resistant disease with more than 15% bone marrow blasts after induction
course

- Primary refractory disease

- Failure to achieve first complete remission after at least 2 induction
courses

- Relapse from first remission with more than 5% bone marrow blasts

- Complete or partial remission following 1 induction course with adverse
cytogenetic abnormalities at diagnosis

- No acute promyelocytic leukemia

- No chronic myeloid leukemia in blast transformation

- No prior relapse from a second or greater remission

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine clearance at least 30 mL/min

Other:

- No other active malignancy

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified