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LeukemiaPhase 3NCT00002926

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

A Phase 3 study testing cytarabine, etoposide and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 40 sites in 9 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
cytarabine, etoposide and idarubicin
Type of treatment
Surgery or procedure
How many people
80 participants
Where
40 sitesin 9 countries
Study dates
Dec 1996to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

40 sites in 9 countries.

40 sites in 9 countries

Netherlands10 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1001HV

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA

  • Erasmus Medical Center

    Rotterdam, 3075 EA

  • Leyenburg Ziekenhuis

    The Hague, 2545 CH

  • Sophia Ziekehuis

    Zwolle, 8000 GK

Other trials in Netherlands

Belgium8 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • A.Z. St. Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

Other trials in Belgium

Switzerland6 sites

  • University Hospital

    Basel, CH-4031

  • Ospedale San Giovanni

    Bellinzona, CH-6500

  • Inselspital, Bern

    Bern, CH-3010

  • Hopital Cantonal Universitaire de Geneva

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Germany5 sites

  • Universitaetsklinik Duesseldorf

    Düsseldorf, D-40225

  • Universitaetsklinik und Strahlenklinik - Essen

    Essen, D-45122

  • Medizinische Klinik und Poliklinik

    Heidelberg, 92093-0671

  • Klinikum Grosshadern

    Munich (Muenchen), D-81377

  • Eberhard Karls Universitaet

    Tübingen, D-72076

Other trials in Germany

France4 sites

  • Hopital Edouard Herriot

    Lyon, 69437

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hotel Dieu de Paris

    Paris, 75181

  • Hopital Necker

    Paris, 75743

Other trials in France

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg (Goteborg), S-413 45

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Orebro University Hospital

    Örebro, 70185

  • Huddinge University Hospital

    Stockholm, SE-141 86

Other trials in Sweden

Croatia1 site

  • University Hospital Rebro

    Zagreb, 10000

Other trials in Croatia

Czechia1 site

  • Institute of Hematology and Blood Transfusion

    Prague, 128 20

Other trials in Czechia

Italy1 site

  • Ospedale San Eugenio

    Rome, 00144

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
cytarabine, etoposide, idarubicin, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation
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
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002926
Sponsor's protocol ID
CDR0000065336
Other IDs
EORTC-06961
Status last verified
May 2001
First submitted
1 Nov 1999
Last updated
27 May 2010
Results posted
No

Publications

  • 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.

    PubMed 20494931

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cytarabine, etoposide and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 40 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Netherlands, Belgium, Switzerland, Germany, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.

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