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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia Clinical research trials and Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia  Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
For Condition: Refractory Anemia,Myeloid Leukemia,Myelodysplastic Syndromes,Refractory Cytopenia
Status: No longer recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: 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.
Details: OBJECTIVES: - Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine (Ara-C) performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes (MDS) or acute myelogenous leukemia secondary to MDS. - Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor. - Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation. - Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course. - Assess recovery time of granulocyte and platelet counts following each treatment step. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TheoWitte, Study Chair, University Medical Center Nijmegen
Klinikum Grosshadern
Munich (Muenchen), , D-81377
Germany
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
University Hospital Rebro
Zagreb, , 10000
Croatia
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Centre Antoine Lacassagne
Nice, , 06189
France
University Hospital of Linkoping
Linkoping, , S-581 85
Sweden
Hopital Edouard Herriot
Lyon, , 69437
France
Universitaetsklinik Duesseldorf
Duesseldorf, , D-40225
Germany
Hopital Necker
Paris, , 75743
France
University Hospital
Basel, , CH-4031
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
A.Z. St. Jan
Brugge, , 8000
Belgium
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Erasmus Medical Center
Rotterdam, , 3075 EA
Netherlands
Sahlgrenska University Hospital
Gothenburg (Goteborg), , S-413 45
Sweden
Sophia Ziekehuis
Zwolle, , 8000 GK
Netherlands
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , 5530
Belgium
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Hotel Dieu de Paris
Paris, , 75181
France
Eberhard Karls Universitaet
Tuebingen, , D-72076
Germany
Kantonsspital - St. Gallen
St. Gallen, , CH-9007
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Ospedale San Eugenio
Rome, , 00144
Italy
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Inselspital, Bern
BERN, , CH-3010
Switzerland
Orebro University Hospital
OREBRO, , 70185
Sweden
Leyenburg Ziekenhuis
's-Gravenhage, , 2545 CH
Netherlands
Institute of Hematology and Blood Transfusion
Prague, , 128 20
Czech Republic
Medizinische Klinik und Poliklinik
Heidelberg, , 92093-0671
Germany
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Cliniques Universitaires Saint-Luc
Brussels, , 1200
Belgium
Huddinge University Hospital
Stockholm, , SE-141 86
Sweden
Additional Information:
Study ID Numbers: CDR0000065336; EORTC-06961
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002926
Other Myelodysplastic Syndromes Studies:
1. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
2. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
3. Monoclonal Antibody Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma
4. Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
5. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other Clinical Trials
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
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