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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002926
Recruitment Status : Unknown
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 27, 2010
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: cytarabine Drug: etoposide Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : December 1996

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16-60

Performance status:

  • WHO 0-2


  • 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


  • Bilirubin no greater than 1.5 times normal


  • Creatinine no greater than 1.5 times normal


  • No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50%


  • No severe concomitant neurological disease


Biologic therapy:

  • No treatments within the past 4 weeks of:

    • Biological response modifiers AND/OR
    • Low dose Ara-C


  • No prior intensive treatment for MDS or AML

Endocrine therapy:

  • Not specified


  • No prior treatment for MDS or AML


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002926

  Show 40 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Theo De Witte, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen

Publications of Results:
Layout table for additonal information Identifier: NCT00002926     History of Changes
Other Study ID Numbers: CDR0000065336
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2001
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:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic