NL-OMON39282
Completed
Phase 2
A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia - Midostaurin for relapsed/refractory pediatric leukemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Relapsed/refractory leukemia
- Sponsor
- ovartis
- Enrollment
- 5
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients must have a documented diagnosis of one of the following
- •MLL\-rearranged ALL, refractory to standard induction treatment or in
- •first or subsequent relapse
- •FLT3\-mutated AML refractory to standard induction (after failure of at
- •least 2 different induction chemotherapy regimens) or refractory to reinduction
- •at 1st relapse (after failure of the first re\-induction course), or
- •in second or greater relapse
- •2\. Patients must be less than 18 years of age and \>\=3 months of age.
- •3\. Patients must have a Lansky/Karnofsky performance status \>\= 60\.
- •4\. Patients must have the following laboratory values reflecting appropriate
Exclusion Criteria
- •1\. Patients with symptomatic leukemic CNS involvement.
- •2\. Patients with isolated extramedullary leukemia.
- •3\. Patients must have recovered from prior cytotoxic chemotherapy, and a
- •minimum wash\-out time of previous chemotherapy of 72 hours should be
- •taken into account. For intrathecal chemotherapy, the minimum wash\-out time is 48 hours
- •4\. Patients who had prior allogeneic, syngeneic or autologous bone marrow
- •or stem cell transplant less than 2 months from Day 1
- •5\. Patients who have received any investigational agent within 30 days or 5
- •half lives, whichever is greater, prior to Day 1\.
- •6\. Patients who have had prior treatment with a FLT3 inhibiting drug or
Outcomes
Primary Outcomes
Not specified
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