Clinical trial · Interventional
Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC #141633) and Low-Dose Cytarabine
NCT00003694CI-TRIAL-00010618completedPhase 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| omacetaxine mepesuccinate | Drug | Omacetaxine Mepesuccinate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (omacetaxine mepesuccinate, cytarabine)
- description
- 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.
- interventionNames
- Drug: omacetaxine mepesuccinate
- Drug: cytarabine
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Complete cytogenetic, major cytogenetic, and hematologic response rate
- timeFrame
- Up to 9 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * 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
References
Publications (0)
Data not yet available
No reference posted for this study.