Status:
COMPLETED
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy ...
Detailed Description
This was a Phase II, multi-center trial consisting of two parts; Part 1: an open label, safety evaluation part in Japan only (minimum of three evaluable subjects) and Part 2: a double-blind, randomize...
Eligibility Criteria
Inclusion
- Diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible
- Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as determined by analysis in a Novartis designated laboratory An exception will be patients who are enrolled into the part 1 in Japan, who may be treated with midostaurin irrespective of AML FLT3 genotype.
- Patients must meet the following laboratory value criteria that indicate adequate organ function at the screening visit:
- Estimated creatinine clearance ≥ 30 ml/min
- Total bilirubin ≤ 1.5 x ULN, except in the setting of isolated Gilbert syndrome
- Aspartate transaminase (AST) ≤ 3.0 x ULN
- Alanine transaminase (ALT) ≤ 3.0 x ULN
- Suitability for intensive chemotherapy in the judgment of the investigator
Exclusion
- Neurologic symptoms suggestive of CNS leukemia unless CNS leukemia has been excluded by a lumbar puncture. Patients with CSF fluid positive for AML blasts are not eligible
- Developed therapy-related AML after prior radiotherapy (RT) or chemotherapy for another cancer or disorder
- Known hypersensitivity to midostaurin, cytarabine or daunorubicin or to any of the excipients of midostaurin/placebo, cytarabine or daunorubicin
- Abnormal chest X-ray unless the abnormality represents a non-active, or non-clinically significant finding, such as scarring (subjects with controlled non active lung infection are eligible)
- Known impairment of gastrointestinal (GI) function or GI disease that might alter significantly the absorption of midostaurin
- Cardiac or cardiac repolarization abnormality
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 4 months after stopping medication
Key Trial Info
Start Date :
April 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03280030
Start Date
April 6 2018
End Date
November 14 2022
Last Update
March 20 2025
Active Locations (34)
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1
Novartis Investigative Site
Pokfulam, Hong Kong
2
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 466-8650
3
Novartis Investigative Site
Toyoake, Aichi-ken, Japan, 470 1192
4
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577