A phase II study of efficacy and safety of Pegasys in patients with Chronic Phase Chronic Myeloid Leukaemia in PCR+ve complete or near complete cytogenetic remission on Glivec at 600 mg daily or maximum tolerated dose (CML07)

Funding

Commercial sector/Industry,Novartis Australia

Scientific enquiries

Dr Kerry Taylor

Brief Summary

A Phase II study of efficacy and safety of Pegasys® in patients with chronic myeloid leukaemia (CML) in complete or near complete cytogenetic remission but persisting molecular positivity at 600 mg or maximum tolerated dose of Glivec Patients with Ph+ve CML with complete or near complete cytogenetic responses to Glivec® at 600 mg or maximum tolerated dose, but with persisting molecular positivity. Primary Objective: To assess whether adding Pegasys® to Glivec® in these patients improves molecula .... A Phase II study of efficacy and safety of Pegasys® in patients with chronic myeloid leukaemia (CML) in complete or near complete cytogenetic remission but persisting molecular positivity at 600 mg or maximum tolerated dose of Glivec Patients with Ph+ve CML with complete or near complete cytogenetic responses to Glivec® at 600 mg or maximum tolerated dose, but with persisting molecular positivity. Primary Objective: To assess whether adding Pegasys® to Glivec® in these patients improves molecular response status (by PCR quantification of bcr-abl transcripts)
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Key Inclusion Criteria

All of the following criteria must be met: Cohort One: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved complete cytogenetic response on Glivec® therapy AND not previously in accelerated phase or blast crisis; 4. Sustained complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit .... All of the following criteria must be met: Cohort One: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved complete cytogenetic response on Glivec® therapy AND not previously in accelerated phase or blast crisis; 4. Sustained complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha- interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed. Cohort Two: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved near complete cytogenetic response on Glivec® therapy OR Achieved a complete cytogenetic response on Glivec® therapy AND previously in accelerated phase or blast crisis; 4. Sustained complete or near-complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha-interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed;
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Key Exclusion Criteria