A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)
- Conditions
- blood cancer10024324leukemia
- Registration Number
- NL-OMON51567
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 3
1. Males or females >= 18 years of age.
2. CML-CP within 3 months of diagnosis.
3. Diagnosis of CML-CP (European Leukemia Network 2020 criteria) with
cytogenetic confirmation of the Ph chromosome. Documented CML-CP will meet all
the criteria as mentioned in item 4 on page 10 of the protocol.
4. Evidence of typical BCR::ABL1 transcript. See item 5 on protocol page 10 for
details.
5. ECOG performance status of 0 or 1.
6. Adequate end organ function as defined in item 7 on protocol page 10.
7. The laboratory values mentioned in item 8 on protocol pages 10/11 must be
within normal limits or must have been corrected to within normal limits with
supplements prior to randomization
1. Previous treatment of CML with any other anticancer agents or prior stem
cell transplant, with the exception of hydroxyurea and/or anagrelide.
2. Known cytopathologically confirmed CNS infiltration.
3. Impaired cardiac function or cardiac repolarization abnormality. See item 3
on protocol page 11 for details.
4. Severe and/or uncontrolled concurrent medical disease that in the opinion of
the investigator could cause unacceptable safety risks or compromise compliance
with the protocol. See item 5 on protocol page 11 for examples.
5. History of significant bleeding disorder. See item 5 on protocol page 11 for
details.
6. Major surgery within 4 weeks prior to study entry or not recovered from
prior surgery.
7. History of other active malignancy within 3 years prior to study entry. See
item 7 on protocol page 11 for exceptions.
8. History of acute pancreatitis within 1 year prior to randomization or
medical history of chronic pancreatitis.
9. History of chronic liver disease leading to severe hepatic impairment, or
ongoing acute liver disease.
10. Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV)
infection. See item 10 on protocol page 12 for details.
11. History of HIV unless well-controlled on a stable dose of anti-retroviral
therapy at the time of screening.
12. Impairment of GI function or GI disease that may significantly alter the
absorption of study treatment. See item 12 on protocol page 12 for details...
13. Participation in a prior investigational study within 30 days prior to
randomization or within 5 half-lives of the investigational product, whichever
is longer.
14. Pregnant or lactating women
15. Women of child-bearing potential not using highly effective methods of
contraception. See item 15 on protocol page 12 for details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to discontinuation of study treatment due to adverse event.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Discontinuation due to lack of efficacy, treatment failure, disease<br /><br>progression, suboptimal response, death.<br /><br>Patient-reported disease-related symptoms, functioning, and health-related<br /><br>quality of life.<br /><br>Adverse events.</p><br>