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

NCT ID: NCT00002926

Last Updated: 2010-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-12-31

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cytarabine

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

idarubicin

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Principal Investigators

Theo De Witte, MD, PhD

Role: STUDY_CHAIR

Universitair Medisch Centrum St. Radboud - Nijmegen

Locations

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

A.Z. St. Jan

Bruges, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Hopital Universitaire Erasme

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, , Belgium

University Hospital Rebro

Zagreb, , Croatia

Institute of Hematology and Blood Transfusion

Prague, , Czechia

Hopital Edouard Herriot

Lyon, , France

Centre Antoine Lacassagne

Nice, , France

Hotel Dieu de Paris

Paris, , France

Hopital Necker

Paris, , France

Universitaetsklinik Duesseldorf

Düsseldorf, , Germany

Universitaetsklinik und Strahlenklinik - Essen

Essen, , Germany

Medizinische Klinik und Poliklinik

Heidelberg, , Germany

Klinikum Grosshadern

Munich (Muenchen), , Germany

Eberhard Karls Universitaet

Tübingen, , Germany

Ospedale San Eugenio

Rome, , Italy

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

University Medical Center Nijmegen

Nijmegen, , Netherlands

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Leyenburg Ziekenhuis

The Hague, , Netherlands

Sophia Ziekehuis

Zwolle, , Netherlands

Sahlgrenska University Hospital

Gothenburg (Goteborg), , Sweden

University Hospital of Linkoping

Linköping, , Sweden

Orebro University Hospital

Örebro, , Sweden

Huddinge University Hospital

Stockholm, , Sweden

University Hospital

Basel, , Switzerland

Ospedale San Giovanni

Bellinzona, , Switzerland

Inselspital, Bern

Bern, , Switzerland

Hopital Cantonal Universitaire de Geneva

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Countries

Belgium; Croatia; Czechia; France; Germany; Italy; Netherlands; Sweden; Switzerland

References

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.

Reference Type: RESULT

PMID: 20494931 (View on PubMed)

Other Identifiers

EORTC-06961

Identifier Type: -

Identifier Source: secondary_id

CDR0000065336

Identifier Type: -

Identifier Source: org_study_id