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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: March 9, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 80
Study Start Date: December 1996
Detailed Description:

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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002926

  Hide Study Locations
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
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Theo De Witte, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009