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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002926
• Other study ID #: CDR0000065336
• Secondary ID: EORTC-06961
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: May 26, 2010
• Start date: December 1996

Study information

• Verified date: May 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• cytarabine

• etoposide

• idarubicin

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	A.Z. St. Jan	Brugge
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Clinique Universitaire De Mont-Godinne	Mont-Godinne Yvoir
Croatia	University Hospital Rebro	Zagreb
Czech Republic	Institute of Hematology and Blood Transfusion	Prague
France	Hopital Edouard Herriot	Lyon
France	Centre Antoine Lacassagne	Nice
France	Hopital Necker	Paris
France	Hotel Dieu de Paris	Paris
Germany	Universitaetsklinik Duesseldorf	Duesseldorf
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Medizinische Klinik und Poliklinik	Heidelberg
Germany	Klinikum Grosshadern	Munich (Muenchen)
Germany	Eberhard Karls Universitaet	Tuebingen
Italy	Ospedale San Eugenio	Rome
Netherlands	Leyenburg Ziekenhuis	's-Gravenhage
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Hospital - Rotterdam Dijkzigt	Rotterdam
Netherlands	Sophia Ziekehuis	Zwolle
Sweden	Sahlgrenska University Hospital	Gothenburg (Goteborg)
Sweden	University Hospital of Linkoping	Linkoping
Sweden	Orebro University Hospital	Orebro
Sweden	Huddinge University Hospital	Stockholm
Switzerland	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	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Croatia,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Sweden,  Switzerland, 

References & Publications (1)

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 — View Citation