Clinical trial · Interventional
Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia
NCT00006364CI-TRIAL-00009065completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Chronic Myelogenous Leukemia | Childhood Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Phase Chronic Myelogenous Leukemia | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Relapsing Chronic Myelogenous Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| omacetaxine mepesuccinate | Drug | Omacetaxine Mepesuccinate | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (omacetaxine mepesuccinate)
- description
- 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.
- interventionNames
- Drug: omacetaxine mepesuccinate
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Maximum-tolerated dose (MTD) of homoharringtonine as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
- timeFrame
- 14 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * At least 2 months * Bilirubin no greater than 2.0 mg/dL * Creatinine less than 2.0 mg/dL * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Fertile patients must use effective contraception
References
Publications (0)
Data not yet available
No reference posted for this study.