Overview

Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome

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 idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Busulfan
Cyclophosphamide
Idarubicin
Melphalan
Criteria
DISEASE CHARACTERISTICS: Acute myelogenous leukemia (AML), acute lymphocytic leukemia
(ALL), lymphocytic leukemia (LL) or myelodysplastic syndromes (MDS) with at least one of
the following high risk criteria: T-cell depleted stem cells or autologous stem cells
Second complete response (CR) Previous CNS involvement No CR First CR achieved more than 5
weeks after start of remission-induction therapy Poor prognostic cytogenetic features:
t(9;22), t(8;14), t(11;14), 11q23 anomalies, -5/5q-anomalies, -7/7q-anomalies, +8, complex
cytogenetics Postcytotoxic/secondary AML Chronic myelogenous leukemia (CML) with at least
one of the following high risk criteria: T-cell depleted stem cells Not in first chronic
phase Non-Hodgkin's lymphoma or multiple myeloma Autologous stem cells

PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: WHO 0-2 Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No severe heart failure requiring
diuretics No ejection fraction of less than 50% Neurologic: No severe concurrent
neurological or psychiatric disease Other: HIV negative No allogeneic stem cells from
donors other than HLA identical sibling(s)

PRIOR CONCURRENT THERAPY: See Disease Characteristics