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

May 26, 2010 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Algemeen Ziekenhuis Middelheim
      • Brugge, Belgium, 8000
        • A.Z. St. Jan
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Mont-Godinne Yvoir, Belgium, 5530
        • Clinique Universitaire De Mont-Godinne
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Rebro
  • Czech Republic
      • Prague, Czech Republic, 128 20
        • Institute of Hematology and Blood Transfusion
  • France
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75743
        • Hôpital Necker
      • Paris, France, 75181
        • Hotel Dieu de Paris
  • Germany
      • Duesseldorf, Germany, D-40225
        • Universitaetsklinik Duesseldorf
      • Essen, Germany, D-45122
        • Universitaetsklinik und Strahlenklinik - Essen
      • Heidelberg, Germany, 92093-0671
        • Medizinische Klinik und Poliklinik
      • Munich (Muenchen), Germany, D-81377
        • Klinikum Großhadern
      • Tuebingen, Germany, D-72076
        • Eberhard Karls Universitaet
  • Italy
      • Rome, Italy, 00144
        • Ospedale San Eugenio
  • Netherlands
      • 's-Gravenhage, Netherlands, 2545 CH
        • Leyenburg Ziekenhuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus Medical Center
      • Rotterdam, Netherlands, 3000 CA
        • University Hospital - Rotterdam Dijkzigt
      • Zwolle, Netherlands, 8000 GK
        • Sophia Ziekehuis
  • Sweden
      • Gothenburg (Goteborg), Sweden, S-413 45
        • Sahlgrenska University Hospital
      • Linkoping, Sweden, S-581 85
        • University Hospital of Linkoping
      • Orebro, Sweden, 70185
        • Örebro University Hospital
      • Stockholm, Sweden, SE-141 86
        • Huddinge University Hospital
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bellinzona, Switzerland, CH-6500
        • Ospedale San Giovanni
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneva
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Theo De Witte, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065336
  • EORTC-06961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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