NCT00002719

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in the bone marrow or peripheral blood and may help a person's immune system recover after chemotherapy and radiation therapy. Combining more than one drug and giving drugs in different ways may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1995

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

April 29, 2004

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

5.9 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

LeukemiaNeutropenia

Keywords

untreated adult acute myeloid leukemiaadult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute megakaryoblastic leukemia (M7)secondary acute myeloid leukemiaadult acute monocytic leukemia (M5b)neutropeniaadult acute minimally differentiated myeloid leukemia (M0)

Interventions

filgrastimBIOLOGICAL
amsacrineDRUG
carmustineDRUG
cytarabineDRUG
etoposideDRUG
idarubicinDRUG
mitoxantrone hydrochlorideDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age61 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Acute myeloblastic leukemia (AML) At least 30% blast cells in bone marrow smear Secondary AML eligible, as follows: Secondary to myelodysplastic syndrome (but not other myeloproliferative diseases) Secondary to cured Hodgkin's disease or other cured malignancy Secondary to alkylating agents or radiation for other reasons Acute promyelocytic leukemia (M3) referred to the collaborative Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto-EORTC protocol (EORTC-06952) No blast crisis of chronic myeloid leukemia PATIENT CHARACTERISTICS: Age: 61 to 80 Performance status: WHO 0-2 Life expectancy: No marked impairment from disease other than AML Hematopoietic: Not applicable Hepatic: Bilirubin less than 2 x ULN Renal: Creatinine less than 2 x ULN Cardiovascular: LVEF at least 50% No severe cardiac disease Pulmonary: No severe pulmonary disease Other: HIV seronegative (if tested) No uncontrolled infection No severe neurologic, metabolic, or psychiatric disease No other concomitant disease that precludes protocol therapy No other progressive malignant disease PRIOR CONCURRENT THERAPY: No prior chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Related Publications (3)

  • Thomas X, Suciu S, Rio B, Leone G, Broccia G, Fillet G, Jehn U, Feremans W, Meloni G, Vignetti M, de Witte T, Amadori S. Autologous stem cell transplantation after complete remission and first consolidation in acute myeloid leukemia patients aged 61-70 years: results of the prospective EORTC-GIMEMA AML-13 study. Haematologica. 2007 Mar;92(3):389-96. doi: 10.3324/haematol.10552.

    PMID: 17339189RESULT

  • Amadori S, Suciu S, Jehn U, Stasi R, Thomas X, Marie JP, Muus P, Lefrere F, Berneman Z, Fillet G, Denzlinger C, Willemze R, Leoni P, Leone G, Casini M, Ricciuti F, Vignetti M, Beeldens F, Mandelli F, De Witte T; EORTC/GIMEMA Leukemia Group. Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia: final results of AML-13, a randomized phase-3 study. Blood. 2005 Jul 1;106(1):27-34. doi: 10.1182/blood-2004-09-3728. Epub 2005 Mar 10.

    PMID: 15761020RESULT

  • Jehn U, Suciu S, Thomas X, Lefrere F, Muus P, Berneman Z, Marie JP, Adamo F, Fillet G, Nobile F, Ricciuti F, Leone G, Rizzoli V, Montanaro M, Beeldens F, Fazi P, Mandelli F, Willemze R, de Witte T, Amadori S. Non-infusional vs intravenous consolidation chemotherapy in elderly patients with acute myeloid leukemia: final results of the EORTC-GIMEMA AML-13 randomized phase III trial. Leukemia. 2006 Oct;20(10):1723-30. doi: 10.1038/sj.leu.2404356. Epub 2006 Aug 17.

    PMID: 16932345RESULT

MeSH Terms

Conditions

LeukemiaNeutropeniaLeukemia, Erythroblastic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

FilgrastimAmsacrineCarmustineCytarabineEtoposideIdarubicinMitoxantronePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesAnthraquinonesAnthronesAnthracenesQuinonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Roel Willemze, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

  • Franco Mandelli, MD

    Azienda Policlinico Umberto Primo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 29, 2004

Study Start

December 1, 1995

Primary Completion

November 1, 2001

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

IT(1)