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LeukemiaPhase 1/2NCT00840684

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

A Phase 1/2 study testing amsacrine, busulfan and cytarabine in people with Leukemia, run by Institut Paoli-Calmettes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia
What is being tested?
amsacrine, busulfan and cytarabine
Type of treatment
Surgery or procedure
How many people
135 participants
Where
1 siteFrance
Study dates
Jan 2009to May 2011
Phase
Phase 1/2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Marseille, 13273

Other trials in France

About this study

Official title: A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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)

Secondary

  • 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.

Conditions
Leukemia
Being tested
amsacrine, busulfan, cytarabine, daunorubicin hydrochloride, laromustine
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, untreated adult acute myeloid leukemia
Medical subject headings
Leukemia, Congenital Abnormalities

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (phase I)

  2. Rate of complete remission (phase II)

Timeline

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

  1. First posted10 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2011

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00840684
Sponsor's protocol ID
CDR0000634230
Other IDs
IPC-LAM-HR, IPC-2006-007, INCA-RECF0902, EUDRACT-2007-001082-15
Status last verified
Jul 2009
First submitted
7 Feb 2009
Last updated
13 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing amsacrine, busulfan and cytarabine in people with Leukemia, run by Institut Paoli-Calmettes at 1 site in France.

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: finished, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Dose-limiting toxicity (phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00840684.

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 13 May 2011.

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