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Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhase 2NCT00003694

Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

A Phase 2 study testing omacetaxine mepesuccinate, cytarabine and laboratory biomarker analysis in people with Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Chronic Phase Chronic Myelogenous Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

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

Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
omacetaxine mepesuccinate, cytarabine and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Mar 1999to Aug 2003
Phase
Phase 2

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologic diagnosis of chronic myelogenous leukemia (CML) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
  • Patients must meet one or more of the following criteria:
  • Cytogenetically determined Philadelphia chromosome (Ph+)
  • BCR/ABL protein detectable by immunoblotting
  • Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
  • BCR/ABL translocation present by fluorescence in situ hybridization (FISH)
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  • Registration within eight weeks of the diagnosis and confirmation of Ph+ or BCR/ABL+ CML
  • No more than eight weeks of prior hydroxyurea therapy
  • No previous therapy with homoharringtonine (HHT)
  • No prior treatment for CML with agents other than hydroxyurea; thus, prior treatment for CML with agents such as interferon, busulfan or cytarabine will render patients ineligible
  • Must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
  • ECOG performance status 0-2
  • Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
  • Bilirubin =< x upper limit of normal
  • Creatinine =< 1.5 mg/dl

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Harvard Cancer Center

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC #141633) and Low-Dose Cytarabine

Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the hematologic and cytogenetic response rate of newly diagnosed patients with BCR/ABL (+) chronic myelogenous leukemia (CML) treated with combined homoharringtonine (omacetaxine mepesuccinate) and low dose cytarabine.

II. To estimate the toxicity of these two drugs given in combination in a cooperative group setting.

SECONDARY OBJECTIVES:

  1. To assess duration of hematological response and incidence of hematological progression for all patients.

II. To assess duration of cytogenetic response in patients continuing protocol therapy beyond the initial nine months.

III. To use quantitative Southern blot monitoring of blood samples to monitor molecular response rates in patients entered onto CALGB treatment studies for CML.

IV. To compare quantitative Southern blot results of blood samples with marrow cytogenetics at the time of complete molecular response.

  1. To use RT-PCR to monitor the frequency of residual disease in patients who have achieved a complete blood Southern blot and marrow cytogenetic response (elimination of BCR/ABL positivity by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE:

Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.

Patients are followed every 6 months for 10 years.

Being tested
omacetaxine mepesuccinate, cytarabine, laboratory biomarker analysis
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • omacetaxine mepesuccinateDrug

    Also called CGX-635, homoharringtonine

    Given IV

  • cytarabineDrug

    Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00003694
Study groupRoleWhat they receive
Treatment (omacetaxine mepesuccinate, cytarabine)ExperimentalPatients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.
Receives: Drug: omacetaxine mepesuccinate; Drug: cytarabine; Other: laboratory biomarker analysis

What is being measured

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

  1. Complete cytogenetic, major cytogenetic, and hematologic response rate

    Two separate single-stage Fleming designs will be used to test hypotheses regarding the major cytogenetic response rate and the complete cytogenetic response rate. Calculated and presented with their 95% confidence intervals.

    Measured: Up to 9 months

Secondary outcomes (3)

  1. Toxicity rates as assessed by Common Terminology Criterial version 2.0

    Measured: Up to 9 months

  2. Duration of hematological response

    Described with Kaplan-Meier curves.

    Measured: Up to 10 years

  3. Time to hematological progression

    Described with Kaplan-Meier curves.

    Measured: Up to 10 years

Timeline

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

  1. First posted5 Dec 2003 (estimated)
  2. Study startMar 1999
  3. Primary completionAug 2003

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003694
Sponsor's protocol ID
NCI-2012-02786
Other IDs
CALGB-19804, U10CA031946
Status last verified
Jun 2013
First submitted
1 Nov 1999
Last updated
5 Jun 2013
Results posted
No

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