Health Condition 1: null- Chronic Myeloid Leukemia
Conditions
Interventions
Intervention1: Omacetaxine mepesuccinate Other Names: Homoharringtonine, OMA, SynriboTM, HHT: Induction Treatment: 1.25 mg per square meter subcutaneously twice daily for 14 consecutive days, every 2
Sponsors
ChemGenex Pharmaceuticals now Teva Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Note: Since there is no upper age limit defined for this trial, for the CTRI registration purpose we have included the upper age limit to be considered as 99 years. Male or female patients, age 18 years or older Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors. Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response). Acceptable Renal and Liver Function Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Sexually active patients and their partners must use an effective double barrier method of contraception
Exclusion criteria
Exclusion criteria: New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition Myocardial infarction in the previous 12 weeks. Other concurrent illness which would preclude study conduct and assessment uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not. Pregnant or lactating. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. Lymphoid Ph+ blast crisis Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving a Clinical Response by Subpopulation. Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase. Participants with Adverse Events by Subpopulation. Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase.Timepoint: Upto 6 months Upto 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response The time from the first reported date of hematologic or cytogenetic response, as defined above, until the earliest date of objective evidence of disease progression, relapse or death.Timepoint: up to 4 years [ Designated as safety issue: No ];Overall Survival The time from the initiation of treatment until death from any cause or the last day of patient contact or evaluation for patients that are lost to follow-up.Timepoint: up to 4 years [ Designated as safety issue: No ];Participants Degree of Suppression of BCR-ABL transcript levelsTimepoint: up to 6 months [ Designated as safety issue: No ];Participants Degree of Suppression of the Philadelphia Chromosome (Ph)Timepoint: up to 6 months [ Designated as safety issue: No];Percentage of CML Participants with Accelerated or Blast Phase Who Return to Chronic PhaseTimepoint: Up to four years [ Designated as safety issue: No ];Percentage of CML Participants with Accelerated or Blast Phase Who Show No Evidence of LeukemiaTimepoint: up to four years [ Designated as safety issue: No ];Percentage of Participants with Extramedullary Disease (EMD) at Baseline Who Achieve a Clinical ResponseTimepoint: up to four years [ Designated as safety issue: No ];The Number of Induction Cycles to Achieve a Clinical ResponseTimepoint: up to 6 months [ Designated as safety issue: No ];Time to Disease Progression The time from the initiation of treatment until the onset date of death, the development of accelerated-phase or blast-crisis CML, or the loss of complete hematologic or major cytogenetic response, whichever comes first.Timepoint: up to 4 years [ Designated as safety issue: No ];Time to Response The time from the initiation of treatment until the date of first reported hematologic or cytogenetic response.Timepoint: up to 6 months [ Designated as safety issue: No ] | — |
Countries
Canada, France, Germany, Hungary, India, Italy, Poland, United Kingdom, United States of America
Contacts
Public ContactJayesh Mahajan
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed