Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cytarabine; Etoposide; Idarubicin

Criteria

DISEASE CHARACTERISTICS:

• Pathological confirmation of one of the following:

• Untreated refractory anemia with excess blasts (RAEB) in transformation

• RAEB with greater than 10% blasts cells in the bone marrow

• Other myelodysplastic syndromes

• Profound cytopenias

• Acute myelogenous leukemia (AML) supervening after overt myelodysplastic syndromes (MDS) of more than 6 months duration

• No blast crisis of chronic myeloid leukemia

• No leukemias supervening after other myeloproliferative disease

• No leukemias supervening after overt MDS of less than 6 months duration

• The following are allowed:

• Secondary acute leukemias following Hodgkin's disease or other malignancies

• Secondary leukemias following exposure to alkylating agents or radiation

PATIENT CHARACTERISTICS:

Age:

• 16-60

Performance status:

• WHO 0-2

Hematopoietic:

• If RAEB, blasts cells of greater than 10% in bone marrow

• Neutrophil count less than 5,000 or Platelet count less than 200,000

• Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater than 2,600

Hepatic:

• Bilirubin no greater than 1.5 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Cardiovascular:

• No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50%

Neurological:

• No severe concomitant neurological disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No treatments within the past 4 weeks of:

• Biological response modifiers AND/OR

• Low dose Ara-C

Chemotherapy:

• No prior intensive treatment for MDS or AML

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior treatment for MDS or AML

Surgery:

• Not specified