NCT00006364

Brief Summary

Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as homoharringtonine, work in different ways to stop cancer cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

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

November 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

5.8 years

First QC Date

October 4, 2000

Last Update Submit

January 22, 2013

Conditions

Childhood Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous LeukemiaRelapsing Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (2)

  • Maximum-tolerated dose (MTD) of homoharringtonine as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)

    14 days

  • Complete hematologic remission (CHR) defined as at least 4 weeks of bone marrow (less than 5% blasts) and peripheral blood with WBC < 10 x 10^9/L and no peripheral blasts, promyelocytes, or myelocytes

    Using a Bayesian approach.

    Up to 6 years

Study Arms (1)

Treatment (omacetaxine mepesuccinate)

EXPERIMENTAL

Remission induction therapy: Patients receive remission induction therapy comprising homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously (SC) twice daily on days 2-14 for course 1. Subsequent courses of remission induction therapy comprise homoharringtonine SC twice daily on days 1-14. Treatment continues monthly for at least 2 courses. Maintenance therapy: Patients with complete hematologic remission receive maintenance therapy comprising homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the absence of disease progression or unacceptable toxicity.

Drug: omacetaxine mepesuccinateOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

omacetaxine mepesuccinateDRUG

Given IV or SC

Also known as: CGX-635, homoharringtonine
Treatment (omacetaxine mepesuccinate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (omacetaxine mepesuccinate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (omacetaxine mepesuccinate)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic phase chronic myelogenous leukemia (CML), as defined by the following:
  • Less than 15% blasts in the peripheral blood (PB) or bone marrow (BM)
  • Less than 20% basophils in the PB or BM
  • Platelet count \> 100,000/mm\^3 (unless related to therapy)
  • Absence of clonal evolution\*
  • Philadelphia chromosome- OR BCR/ABL-positive disease by cytogenetics, fluorescence in situ hybridization, or polymerase chain reaction
  • Failed prior therapy with imatinib mesylate, as defined by any of the following:
  • Failed to achieve or have lost a complete hematologic remission after 3 months of therapy
  • Failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy
  • Failed to achieve or have lost a major or complete cytogenetic response after 12 months of therapy
  • Unable to tolerate imatinib mesylate despite adequate dose adjustment
  • Failed no more than 2 prior treatment regimens (in addition to imatinib mesylate)
  • Treatment with hydroxyurea is not considered one regimen
  • Ineligible for known regimens or protocols of higher efficacy or priority
  • Performance status - Zubrod 0-2
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

Homoharringtonine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HarringtoninesAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Jorge Cortes

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

January 27, 2003

Study Start

November 1, 1999

Primary Completion

September 1, 2005

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)