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

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cytarabine
etoposide
idarubicin
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • A.Z. St. Jan
  • Institut Jules Bordet
  • Hopital Universitaire Erasme
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Clinique Universitaire De Mont-Godinne
  • University Hospital Rebro
  • Institute of Hematology and Blood Transfusion
  • Hopital Edouard Herriot
  • Centre Antoine Lacassagne
  • Hotel Dieu de Paris
  • Hopital Necker
  • Universitaetsklinik Duesseldorf
  • Universitaetsklinik und Strahlenklinik - Essen
  • Medizinische Klinik und Poliklinik
  • Klinikum Grosshadern
  • Eberhard Karls Universitaet
  • Ospedale San Eugenio
  • Leyenburg Ziekenhuis
  • Vrije Universiteit Medisch Centrum
  • Onze Lieve Vrouwe Gasthuis
  • Academisch Medisch Centrum
  • Leiden University Medical Center
  • Academisch Ziekenhuis Maastricht
  • University Medical Center Nijmegen
  • University Hospital - Rotterdam Dijkzigt
  • Erasmus Medical Center
  • Sophia Ziekehuis
  • Sahlgrenska University Hospital
  • University Hospital of Linkoping
  • Orebro University Hospital
  • Huddinge University Hospital
  • University Hospital
  • Ospedale San Giovanni
  • Inselspital, Bern
  • Hopital Cantonal Universitaire de Geneva
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital - St. Gallen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 26, 2010
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00002926
Brief Title
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
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 Type
Interventional

2. Study Status

Record Verification Date
May 2001
Overall Recruitment Status
Unknown status
Study Start Date
December 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theo De Witte, MD, PhD
Organizational Affiliation
Universitair Medisch Centrum St. Radboud - Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
A.Z. St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Clinique Universitaire De Mont-Godinne
City
Mont-Godinne Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University Hospital Rebro
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Institute of Hematology and Blood Transfusion
City
Prague
ZIP/Postal Code
128 20
Country
Czech Republic
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Universitaetsklinik Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik
City
Heidelberg
ZIP/Postal Code
92093-0671
Country
Germany
Facility Name
Klinikum Grosshadern
City
Munich (Muenchen)
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Eberhard Karls Universitaet
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Ospedale San Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Leyenburg Ziekenhuis
City
's-Gravenhage
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
University Hospital - Rotterdam Dijkzigt
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Sophia Ziekehuis
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Sahlgrenska University Hospital
City
Gothenburg (Goteborg)
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
Orebro University Hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Huddinge University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneva
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20494931
Citation
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, Hellstrom-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.
Results Reference
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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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