An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 260
- Locations
- 4
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with Philadelphia chromosome positive chronic myelogenous leukemia (CML) in myeloid blast crisis (including both newly diagnosed and the participants who received prior therapy for accelerated or blastic phases), defined as either:
- •≥ 30% blast in peripheral blood and /or bone marrow
- •by flow cytometry criteria
- •To be categorized as "newly diagnosed", participants with CML in blast crisis were not to have received specific therapy for CML accelerated or blast phases, with the exception of interferon-alpha or hydroxyurea.
- •serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) not more than 3 times the upper limit of the normal range (ULN) (or not more than 5 times the ULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2 times the ULN, and total serum bilirubin level not more than 3 times the ULN at the laboratory where the analyses were performed.
- •A negative pregnancy test in participants of childbearing potential.
Exclusion Criteria
- •Participants with an eastern cooperative oncology group (ECOG) performance status score ≥
- •Participants previously treated for blast crisis were not to have received any of the following with respect to Day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.
- •Participants receiving any hematopoietic stem cell transplantation within six weeks of Day
- •Participants receiving any other investigational agents within 28 days of Day
- •Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions.
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Imatinib Mesylate (STI571)
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
Intervention: imatinib mesylate (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From first dose until death of the patient, up to 14 years.
Overall survival was defined as the number of events of death, expressed as a percentage, from the start of treatment to death, due to any reason.
Overall Survival (by Month)
Time Frame: From first dose until death of the patient, up to 14 years.
Overall survival was defined as the time between start of treatment and death due to any reason. Overall survival for the participants was calculated by Kaplan-Meier estimates per month. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up.
Secondary Outcomes
No secondary outcomes reported