Working… Menu

Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840684
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : May 13, 2011
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: amsacrine Drug: busulfan Drug: cytarabine Drug: daunorubicin hydrochloride Drug: laromustine Drug: melphalan Drug: mitoxantrone hydrochloride Procedure: allogeneic hematopoietic stem cell transplantation Procedure: autologous hematopoietic stem cell transplantation Phase 1 Phase 2

Detailed Description:



  • To determine the dose of laromustine that can be combined with daunorubicin hydrochloride and cytarabine in patients with previously untreated acute myeloid leukemia with unfavorable cytogenetics. (Phase I)
  • To determine the complete remission rate of this regimen as induction therapy. (Phase II)


  • To determine the complete response rate.
  • To determine the safety profile of this regimen.
  • To determine the overall and relapse-free survival.
  • To evaluate the prognostic value of the molecular markers FLT3, duplications of MLL, and Evi-1.

OUTLINE: This is a multicenter, phase I dose-escalation study of laromustine followed by a phase II study.

  • Induction treatment: Patients receive laromustine IV on day 4, daunorubicin hydrochloride IV on days 1-3, and cytarabine IV continuously on days 1-7. Patients not attaining complete remission (CR) after first induction receive a second induction treatment comprising daunorubicin hydrochloride IV on days 1-3 and cytarabine IV twice daily on days 1-4. Patients in CR after 1 or 2 induction treatments proceed to consolidation treatment.
  • Consolidation treatment: Patients receive mini-consolidation treatment comprising amsacrine on day 1 and cytarabine IV twice daily on days 1-5 followed by 2 courses of continuing consolidation treatment comprising mitoxantrone hydrochloride on days 1 and 2 and cytarabine IV over 12 hours on days 1-5.
  • Allogeneic or autologous stem cell transplantation: Patients receive busulfan four times daily for 4 days and melphalan followed by allogeneic or autologous stem cell transplantation.

After completion of study treatment, patients are followed periodically for 5 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : May 2011

Primary Outcome Measures :
  1. Dose-limiting toxicity (phase I)
  2. Rate of complete remission (phase II)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • Prior hydroxyurea allowed
  • No concurrent disulfiram
  • No concurrent participation in another study with an experimental drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00840684

Layout table for location information
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
Layout table for investigator information
Principal Investigator: Norbert Vey, MD Institut Paoli-Calmettes

Layout table for additonal information Identifier: NCT00840684     History of Changes
Other Study ID Numbers: CDR0000634230
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
untreated adult acute myeloid leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Sensory System Agents
Peripheral Nervous System Agents