NCT01324063

Brief Summary

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3 leukemia

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

November 1, 1986

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1994

Completed
16.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

7.6 years

First QC Date

March 25, 2011

Last Update Submit

July 13, 2012

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (5)

  • Disease-free survival and overall survival in patients who achieve complete remission after induction

  • Toxicity

  • Quality of life

  • Improved therapeutic results as measured by activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery

  • Relative efficacy of autologous bone marrow therapy

Interventions

sargramostimBIOLOGICAL
amsacrineDRUG
cytarabineDRUG
daunorubicin hydrochlorideDRUG
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Newly diagnosed, untreated acute myelogenous leukemia (AML), as follows: Any cytological type according to the FAB classification At least 30% blast cells in bone marrow smear required Secondary acute leukemia eligible, i.e.: AML cured Hodgkin's disease or other malignancy AML following exposure to alkylating agents or radiation The following are specifically excluded: Blast crisis of chronic myeloid leukemia Leukemia supervening after other myeloproliferative disease Leukemia supervening after overt myelodysplastic disorder (e.g., refractory anemia with excess blasts) of more than 6 months' duration PATIENT CHARACTERISTICS: Age: 45-60 Patients 10-45 are eligible for EORTC-06863 Performance status: Not specified Hematopoietic: Not specified Hepatic: No severe concomitant hepatic disease Renal: No severe concomitant renal disease Cardiovascular: No severe concomitant cardiac disease Other: No severe concomitant neurological disease No other progressive malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No more than 7 days of corticosteroids for AML Radiotherapy: No prior radiotherapy Surgery: Not applicable

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

Sponsors & Collaborators

Related Publications (1)

  • Zittoun R, Suciu S, Mandelli F, de Witte T, Thaler J, Stryckmans P, Hayat M, Peetermans M, Cadiou M, Solbu G, Petti MC, Willemze R. Granulocyte-macrophage colony-stimulating factor associated with induction treatment of acute myelogenous leukemia: a randomized trial by the European Organization for Research and Treatment of Cancer Leukemia Cooperative Group. J Clin Oncol. 1996 Jul;14(7):2150-9. doi: 10.1200/JCO.1996.14.7.2150.

    PMID: 8683249RESULT

MeSH Terms

Conditions

Leukemia

Interventions

sargramostimAmsacrineCytarabineDaunorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Robert A. Zittoun, MD

    Hotel Dieu de Paris

    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

March 25, 2011

First Posted

March 28, 2011

Study Start

November 1, 1986

Primary Completion

June 1, 1994

Last Updated

July 16, 2012

Record last verified: 2012-07