RECRUITING

A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.

Official Title

A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

Quick Facts

Study Start:2019-03-13
Study Completion:2029-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03591510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Documented Diagnosis of previously untreated de novo AML according to WHO 2016 criteria
  2. * Presence of a FLT3 mutation status as measured/confirmed by a designated lab with results available prior first dose of Midostaurin
  3. * Patients with Lansky or Karnofsky performance status equal or superior to 60
  4. * Patient with the following laboratory value : AST and ALT ≤ 3times ULN
  5. * Serum Total bilirubin ≤ 1.5times ULN
  6. * Estimated creatinine clearance ≥30ml/min
  1. * Any concurrent malignancy, AML with Philadelphia Chromosome, AML-DS, JMML
  2. * Symptomatic leukemic CNS involvement
  3. * Isolated extramedullary leukemia, secondary AML and MDS
  4. * Acute Promyelocytic Leukemia with the PML RARA rearrangement
  5. * Patient who have received prior treatment with a FLT3 inhibitor. However, up to 1 week of FLT3 inhibitor (except midostaurin) exposure prior to study enrollment is permissible.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Novartis Investigative Site
Aurora, Colorado, 80045
United States
Novartis Investigative Site
Miami, Florida, 33155
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-13
Study Completion Date2029-02-15

Study Record Updates

Study Start Date2019-03-13
Study Completion Date2029-02-15

Terms related to this study

Keywords Provided by Researchers

  • PKC412
  • Acute Myeloid Leukemia
  • AML
  • FLT3-mutated
  • pediatric population
  • midostaurin
  • midostaurin combined with standard chemotherapy
  • single agent post-consolidation therapy
  • untreated FLT3-mutated AML

Additional Relevant MeSH Terms

  • FLT3-mutated Acute Myeloid Leukemia