Omacetaxine in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutatio

Phase 2

Completed

• Conditions: Chronic Myeloid Leukemia; Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12609000373279
• Lead Sponsor: ChemGenex Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients, age 18 years or older.

2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase.

3. The patient will have the T315I BCR-ABL gene mutation.

4. Patients will have failed prior imatinib therapy.

5. Acceptable Renal and Liver Function.

6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

7. Sexually active patients and their partners must use an effective double barrier method of contraception.

Exclusion Criteria

1. New York Heart Association (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.

2. Lymphoid Ph+ blast crisis.

3. Pregnant or lactating.

4. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.

5. Patient is candidate (and has a donor identified) for bone marrow or blood stem cell transplantation.

6. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified