NCT00840684

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_1 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

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

February 7, 2009

Last Update Submit

May 12, 2011

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesuntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (phase I)

  • Rate of complete remission (phase II)

Interventions

amsacrineDRUG
busulfanDRUG
cytarabineDRUG
daunorubicin hydrochlorideDRUG
laromustineDRUG
melphalanDRUG
mitoxantrone hydrochlorideDRUG
allogeneic hematopoietic stem cell transplantationPROCEDURE
autologous hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Untreated disease * No promyelocytic AML * Unfavorable prognosis, defined as at least one of the following: * Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11) * Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea * No AML with favorable or intermediate prognosis * No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Total bilirubin \< 35 μmol/L * Transaminases \< 2.5 times upper limit of normal in the absence of leukemia-related abnormalities * Creatinine \< 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities * Not pregnant or nursing * Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%) * Affiliated with a social security system * No uncontrolled or severe cardiovascular disease, including any of the following: * Myocardial infarction within the past 3 months * Cardiac insufficiency * Uncontrolled arrhythmia * No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix * No patients deprived of freedom or under guardianship (including temporary guardianship) * No psychological, familial, geographical, or social situations that preclude follow-up * No other contraindications to study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior hydroxyurea allowed * No concurrent disulfiram * No concurrent participation in another study with an experimental drug

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

Sponsors & Collaborators

Study Sites (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

MeSH Terms

Conditions

LeukemiaCongenital Abnormalities

Interventions

AmsacrineBusulfanCytarabineDaunorubicinlaromustineMelphalanMitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAnthraquinonesAnthronesAnthracenesQuinones

Study Officials

  • Norbert Vey, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2009

First Posted

February 10, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Last Updated

May 13, 2011

Record last verified: 2009-07

Locations

FR(1)