Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-06961 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytarabine | Drug | |||
| etoposide | Drug | |||
| idarubicin | Drug | |||
| allogeneic bone marrow transplantation | Procedure | |||
| peripheral blood stem cell transplantation | Procedure |
DISEASE CHARACTERISTICS:
Pathological confirmation of one of the following:
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theo De Witte, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Middelheim | Antwerp | 2020 | Belgium | |||
| A.Z. St. Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20494931 | Result | de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellstrom-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bruges |
| 8000 |
| Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Hopital Universitaire Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Clinique Universitaire De Mont-Godinne | Mont-Godinne Yvoir | 5530 | Belgium |
| University Hospital Rebro | Zagreb | 10000 | Croatia |
| Institute of Hematology and Blood Transfusion | Prague | 128 20 | Czechia |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hotel Dieu de Paris | Paris | 75181 | France |
| Hopital Necker | Paris | 75743 | France |
| Universitaetsklinik Duesseldorf | Düsseldorf | D-40225 | Germany |
| Universitaetsklinik und Strahlenklinik - Essen | Essen | D-45122 | Germany |
| Medizinische Klinik und Poliklinik | Heidelberg | 92093-0671 | Germany |
| Klinikum Grosshadern | Munich (Muenchen) | D-81377 | Germany |
| Eberhard Karls Universitaet | Tübingen | D-72076 | Germany |
| Ospedale San Eugenio | Rome | 00144 | Italy |
| Vrije Universiteit Medisch Centrum | Amsterdam | 1001HV | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Leiden University Medical Center | Leiden | 2300 CA | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| University Hospital - Rotterdam Dijkzigt | Rotterdam | 3000 CA | Netherlands |
| Erasmus Medical Center | Rotterdam | 3075 EA | Netherlands |
| Leyenburg Ziekenhuis | The Hague | 2545 CH | Netherlands |
| Sophia Ziekehuis | Zwolle | 8000 GK | Netherlands |
| Sahlgrenska University Hospital | Gothenburg (Goteborg) | S-413 45 | Sweden |
| University Hospital of Linkoping | Linköping | S-581 85 | Sweden |
| Orebro University Hospital | Örebro | 70185 | Sweden |
| Huddinge University Hospital | Stockholm | SE-141 86 | Sweden |
| University Hospital | Basel | CH-4031 | Switzerland |
| Ospedale San Giovanni | Bellinzona | CH-6500 | Switzerland |
| Inselspital, Bern | Bern | CH-3010 | Switzerland |
| Hopital Cantonal Universitaire de Geneva | Geneva | CH-1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D000753 | Anemia, Refractory |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D000740 | Anemia |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D015255 | Idarubicin |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided