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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002926 |
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.
Condition | Intervention | Phase |
Leukemia Myelodysplastic Syndromes |
Drug: cytarabine Drug: etoposide Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
MedlinePlus related topics: | Anemia Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
ChemIDplus related topics: | Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Etoposide phosphate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration |
Estimated Enrollment: | 80 |
Study Start Date: | December 1996 |
OBJECTIVES:
OUTLINE: Induction treatment with idarubicin on days 1,3,5; Ara-C from days 1 through 10; etoposide on days 1 through 5. On day 28 there will be assessment of responses. If there is at least partial response, the cycle will repeat the induction course for another 28 days. There is peripheral blood stem cell collection and cryopreservation following family HLA-typing. If there is no HLA match, then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment.
PROJECTED ACCRUAL: 80 patients will be entered per year.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathological confirmation of one of the following:
The following are allowed:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurological:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No treatments within the past 4 weeks of:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 40 Study Locations |
European Organization for Research and Treatment of Cancer |
Study Chair: | Theo De Witte, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065336, EORTC-06961 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002926 |
Health Authority: | United States: Federal Government |
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