Phase 2
Completed N=103
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Source: ClinicalTrials.gov NCT00375219 ↗Enrolled (actual)
103
Serious AEs
65.1%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population — 77.4; 55.0; 9.5; 59.2 percentage of participants
Summary
To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population |
77.4; 55.0; 9.5; 59.2 | — |
| PRIMARY Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population |
22.6; 5.0; 0; 14.6 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total |
61; 20; 21; 102; 36; 12 | — |
| SECONDARY Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+) |
16.1; 5.0; 0; 10.7; 6.5; 0 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS |
8.1; 12.5; 0; 8.2 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL |
19.2; 15.4; 0; 16.4 | — |
| SECONDARY Percentage of Participants in Each Hematologic Response Category |
77.4; 45.0; 4.8; 56.3; 0; 0 | — |
| SECONDARY Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response |
— | — |
| SECONDARY Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL |
6.0; 0; 0; 4.2; 4.0; 0 | — |
| SECONDARY Number of Treatment Cycles Needed to Achieve Best Hematologic Response |
1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response |
3.0; 2.5; 2.0; 3.0 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response |
0.46; 1.74; NA | — |
| SECONDARY Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response |
NA; NA; NA | — |
| SECONDARY Kaplan-Meier Estimates for Duration of Best Hematologic Response |
9.08; 3.59; 3.31 | — |
| SECONDARY Kaplan-Meier Estimates for Duration of Best Cytogenetic Response |
6.64; 16.35 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Disease Progression |
7.73; 4.74; 2.20; 5.86 | — |
| SECONDARY Kaplan-Meier Estimates for Overall Survival |
49.31; 18.72; 3.45; 21.51 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients, age 18 years or older
- Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
- The patient will have the T315I BCR-ABL gene mutation
- Patients will have failed prior imatinib therapy
- ECOG performance status 0-2
Exclusion Criteria
- NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure
- Myocardial infarction in the previous 12 weeks
- Lymphoid Ph+ blast crisis
Data sourced from ClinicalTrials.gov (NCT00375219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.