18 and older, any sex, with Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total PopulationPrimary· Day 1 up to 6 months
Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last \>= 8 weeks to be considered
Group
Value
95% CI
CML: Chronic Phase
67.4
51.98 – NA
CML: Accelerated Phase
25.8
11.86 – NA
CML: Blast Phase
8.7
1.07 – NA
Total Participants
41.0
31.26 – NA
Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total PopulationPrimary· Day 1 up to 9 months
Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A
Group
Value
95% CI
CML: Chronic Phase
21.7
10.95 – NA
CML: Accelerated Phase
3.2
0.08 – NA
CML: Blast Phase
0
0 – NA
Total Participants
11
5.62 – NA
Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)Secondary· Day 1 up to Month 9
Cytogenetic response categories:
* Complete: 0% Ph+ cells
* Partial: \>0%-35% Ph+ cells
* Minor: \>35%-65% Ph+ cells
* Minimal: \>65%-95% Ph+ cells
* No Response: \>95% Ph+ cells
* Unevaluable: \<20 metaphases were examined and/or response could not be assigned
Complete
Group
Value
95% CI
CML: Chronic Phase
4.3
CML: Accelerated Phase
0
CML: Blast Phase
0
Total Participants
2.0
Partial
Group
Value
95% CI
CML: Chronic Phase
17.4
CML: Accelerated Phase
3.2
CML: Blast Phase
0
Total Participants
9.0
Minor
Group
Value
95% CI
CML: Chronic Phase
8.7
CML: Accelerated Phase
9.7
CML: Blast Phase
0
Total Participants
7.0
Minimal
Group
Value
95% CI
CML: Chronic Phase
6.5
CML: Accelerated Phase
6.5
CML: Blast Phase
4.3
Total Participants
6.0
No Response
Group
Value
95% CI
CML: Chronic Phase
39.1
CML: Accelerated Phase
61.3
CML: Blast Phase
30.4
Total Participants
44.0
Unevaluable
Group
Value
95% CI
CML: Chronic Phase
23.9
CML: Accelerated Phase
19.4
CML: Blast Phase
65.2
Total Participants
32.0
Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUSSecondary· Day 1 up to Month 6
MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region \[BCR\] gene and Abelson proto-oncogene \[ABL\] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.
Group
Value
95% CI
CML: Chronic Phase
13.6
2.9 – 34.9
CML: Accelerated Phase
0
NA – NA
CML: Blast Phase
0
NA – NA
Total Participants
6.8
1.4 – 18.7
Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABLSecondary· Day 1 up to Month 6
MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region \[BCR\] gene and Abelson proto-oncogene \[ABL\] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.
Group
Value
95% CI
CML: Chronic Phase
10.5
2.9 – 24.8
CML: Accelerated Phase
4.3
0.1 – 22.0
CML: Blast Phase
0
NA – NA
Total Participants
6.9
2.3 – 15.5
Percentage of Participants in Each Hematologic Response CategorySecondary· Day 1 up to Month 6
Complete Response (CHR)
* Chronic phase must last at least 8 weeks: WBC \<10\*10\^9/liter, platelets \<450\*10\^9/liter, myelocytes + metamyelocytes \<5% in blood, no blasts or promyelocytes in blood, \<20% basophils in peripheral blood, no extramedullary involvement.
* Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5\*10\^9/liter, platelets 100\*10\^9/liter, no blood blasts, bone marrow blasts \<5%, no extramedullary disease.
Partial Response - CHR plus one or more of the following:
* Persistence of splenomegaly with a reduction of ≥50% from pre-treatme
Complete response
Group
Value
95% CI
CML: Chronic Phase
67.4
CML: Accelerated Phase
19.4
CML: Blast Phase
8.7
Total Participants
39.0
Partial response
Group
Value
95% CI
CML: Chronic Phase
0
CML: Accelerated Phase
3.2
CML: Blast Phase
0
Total Participants
1.0
Hematologic improvement
Group
Value
95% CI
CML: Chronic Phase
0
CML: Accelerated Phase
9.7
CML: Blast Phase
4.3
Total Participants
4.0
Return to chronic phase
Group
Value
95% CI
CML: Chronic Phase
NA
CML: Accelerated Phase
6.5
CML: Blast Phase
0
Total Participants
2.0
No evidence of leukemia
Group
Value
95% CI
CML: Chronic Phase
NA
CML: Accelerated Phase
0
CML: Blast Phase
0
Total Participants
0
No response
Group
Value
95% CI
CML: Chronic Phase
21.7
CML: Accelerated Phase
58.1
CML: Blast Phase
78.3
Total Participants
46.0
Unevaluable
Group
Value
95% CI
CML: Chronic Phase
10.9
CML: Accelerated Phase
3.2
CML: Blast Phase
8.7
Total Participants
8.0
Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical ResponseSecondary· Day 1 up to Month 9
Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).
Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).
Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).
Clinical response
Group
Value
95% CI
CML: Blast Phase
0
Unevaluable
Group
Value
95% CI
CML: Blast Phase
50
Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABLSecondary· Day 1 up to Month 9
Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).
100% reduction
Group
Value
95% CI
CML: Chronic Phase
0
0 – 0
CML: Accelerated Phase
0
0 – 0
CML: Blast Phase
0
0 – 0
Total Participants
0
0 – 0
75-99% reduction
Group
Value
95% CI
CML: Chronic Phase
0
0 – 0
CML: Accelerated Phase
0
0 – 0
CML: Blast Phase
0
0 – 0
Total Participants
0
0 – 0
50-74% reduction
Group
Value
95% CI
CML: Chronic Phase
0
0 – 0
CML: Accelerated Phase
0
0 – 0
CML: Blast Phase
0
0 – 0
Total Participants
0
0 – 0
25-49% reduction
Group
Value
95% CI
CML: Chronic Phase
0
0 – 0
CML: Accelerated Phase
0
0 – 0
CML: Blast Phase
9.1
0.3 – 52.7
Total Participants
1.4
0.0 – 9.1
1-24% reduction
Group
Value
95% CI
CML: Chronic Phase
0
0 – 0
CML: Accelerated Phase
0
0 – 0
CML: Blast Phase
0
0 – 0
Total Participants
0
0 – 0
0% reduction
Group
Value
95% CI
CML: Chronic Phase
78.9
76.4 – 100
CML: Accelerated Phase
91.3
83.9 – 100
CML: Blast Phase
63.3
47.4 – 99.7
Total Participants
80.6
79.9 – 100
Not assessable
Group
Value
95% CI
CML: Chronic Phase
21.1
NA – NA
CML: Accelerated Phase
8.7
NA – NA
CML: Blast Phase
27.3
NA – NA
Total Participants
18.1
NA – NA
Number of Treatment Cycles Needed to Achieve Best Hematologic ResponseSecondary· Day 1 up to Month 6
Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m\^2 twice a day (BID) for the 14 consecutive days.
Group
Value
95% CI
CML: Chronic Phase
1.0
1 – 5
CML: Accelerated Phase
2.0
1 – 4
CML: Blast Phase
2.0
1 – 3
Total Participants
1.0
1 – 5
Number of Treatment Cycles Needed to Achieve Best Cytogenetic ResponseSecondary· Day 1 up to Month 9
Group
Value
95% CI
CML: Chronic Phase
2.0
1 – 9
CML: Accelerated Phase
1.5
1 – 4
CML: Blast Phase
1.0
1 – 1
Total Participants
2.0
1 – 9
Kaplan-Meier Estimates for Time to Onset of Best Hematologic ResponseSecondary· Day 1 up to Month 6
Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last \>= 8 weeks to be considered meaningful.
Group
Value
95% CI
CML: Chronic Phase
1.38
0.49 – 1.84
CML: Accelerated Phase
NA
4.14 – NA
CML: Blast Phase
NA
NA – NA
Total Participants
5.03
3.13 – NA
Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic ResponseSecondary· Day 1 up to Month 9
Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows \>0% - 35% Ph+ cells.
Group
Value
95% CI
CML: Chronic Phase
NA
NA – NA
CML: Accelerated Phase
NA
NA – NA
CML: Blast Phase
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 4 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Omacetaxine
Serious: 63/100 (63%)
Deaths: —
Serious adverse events (58 terms)
Reaction
System
Omacetaxine
Febrile neutropenia
Blood and lymphatic system disorders
—
Disease progression
General disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Bone marrow failure
Blood and lymphatic system disorders
—
Pneumonia
Infections and infestations
—
Diarrhoea
Gastrointestinal disorders
—
Pyrexia
General disorders
—
Anaemia
Blood and lymphatic system disorders
—
Sepsis
Infections and infestations
—
Hypercalcaemia
Metabolism and nutrition disorders
—
Cerebral haemorrhage
Nervous system disorders
—
Febrile bone marrow aplasia
Blood and lymphatic system disorders
—
Pancytopenia
Blood and lymphatic system disorders
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Stomatitis
Gastrointestinal disorders
—
Fatigue
General disorders
—
Catheter sepsis
Infections and infestations
—
Lung infection
Infections and infestations
—
Failure to thrive
Metabolism and nutrition disorders
—
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02440568 — AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients
· Phase 1, PHASE2
· terminated
NCT02078960 — A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Pat
· Phase 1, PHASE2
· terminated
NCT00375219 — Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BC
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 28 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00462943.