EUCTR2008-006931-11-FR
Active, not recruiting
Not Applicable
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 - N/A
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- in pediatric patients with relapsed or refractory leukemia
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 22
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients must have a documented diagnosis with relapsed or refractory leukemia’s, including of one of the following types:
- •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.
- •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\. An investigational agent is
- •an agent with no approved medical uses in adults or pediatrics.
Outcomes
Primary Outcomes
Not specified
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