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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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ClinicalTrials.gov 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
Sponsor:
Information provided by:

November 1, 1999
January 27, 2003
May 27, 2010
December 1996
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Complete list of historical versions of study NCT00002926 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
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

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:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: idarubicin
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
Not Provided
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, Hellström-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
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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
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Croatia,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Sweden,   Switzerland
 
 
NCT00002926
CDR0000065336
EORTC-06961
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European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Theo De Witte, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP