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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002926 |
Purpose
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 |
| 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.
Eligibility| 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:
Contacts and Locations
Hide Study Locations| Belgium | |
| A.Z. St. Jan | |
| Brugge, Belgium, 8000 | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| Clinique Universitaire De Mont-Godinne | |
| Mont-Godinne Yvoir, Belgium, 5530 | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Croatia | |
| University Hospital Rebro | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Institute of Hematology and Blood Transfusion | |
| Prague, Czech Republic, 128 20 | |
| France | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| Hopital Necker | |
| Paris, France, 75743 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Germany | |
| Eberhard Karls Universitaet | |
| Tuebingen, Germany, D-72076 | |
| Klinikum Grosshadern | |
| Munich (Muenchen), Germany, D-81377 | |
| Medizinische Klinik und Poliklinik | |
| Heidelberg, Germany, 92093-0671 | |
| Universitaetsklinik Duesseldorf | |
| Duesseldorf, Germany, D-40225 | |
| Universitaetsklinik und Strahlenklinik - Essen | |
| Essen, Germany, D-45122 | |
| Italy | |
| Ospedale San Eugenio | |
| Rome, Italy, 00144 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Leyenburg Ziekenhuis | |
| 's-Gravenhage, Netherlands, 2545 CH | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1001HV | |
| Sophia Ziekehuis | |
| Zwolle, Netherlands, 8000 GK | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Sweden | |
| Huddinge University Hospital | |
| Stockholm, Sweden, SE-141 86 | |
| Orebro University Hospital | |
| Orebro, Sweden, 70185 | |
| Sahlgrenska University Hospital | |
| Gothenburg (Goteborg), Sweden, S-413 45 | |
| University Hospital of Linkoping | |
| Linkoping, Sweden, S-581 85 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland, CH-6500 | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| Study Chair: | Theo De Witte, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
More Information
| Study ID Numbers: | CDR0000065336, EORTC-06961 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002926 History of Changes |
| Health Authority: | United States: Federal Government |
|
secondary acute myeloid leukemia refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory cytopenia with multilineage dysplasia childhood myelodysplastic syndromes |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses |
Etoposide Cytarabine Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Idarubicin Bone Marrow Diseases Antineoplastic Agents, Phytogenic |