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Protein Kinase Inhibitor
Midostaurin + Chemotherapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented Diagnosis of previously untreated de novo AML according to WHO 2016 criteria
Presence of a FLT3 mutation status as measured/confirmed by a designated lab with results available prior first dose of Midostaurin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to 5 years follow-up of last patient
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of midostaurin when combined with standard chemotherapy in children with a specific type of leukemia. The study will be done in two parts and will involve giving the drug to children over a period of several months.
Who is the study for?
This trial is for pediatric patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. They must have a certain level of physical function, normal liver and kidney tests, and no prior treatment with FLT3 inhibitors or other cancers. Patients with specific types of AML or leukemia in the brain are excluded.Check my eligibility
What is being tested?
The study tests Midostaurin combined with standard chemotherapy to see its safety, how well it works, and how the body processes it in children with AML. It includes two phases: one to find the best dose and another to assess long-term effects over several treatment cycles followed by continuous therapy.See study design
What are the potential side effects?
Midostaurin may cause side effects like nausea, vomiting, diarrhea, weakness, headache, mouth sores, rash or allergic reactions. Chemotherapy can lead to hair loss, infection risk increase due to low blood cell counts, bleeding issues from low platelets and potential damage to organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new diagnosis of AML according to the latest standards.
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My lab tests show a FLT3 mutation.
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My kidneys are working well enough (creatinine clearance ≥ 30 ml/min).
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I can care for myself but may need occasional help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment up to 5 years follow-up of last patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment up to 5 years follow-up of last patient
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 of the study: Occurence of dose limiting toxicities (DLT)
Part 2 of the study: To evaluate Safety of midostaurin (30mg/m2 bid or 1 mg/kg bid for participants <10 kg body weight) in sequential combination with chemotherapy followed by 12 cycles of midostaurin post-consolidation therapy.
Part 2 of the study: To evaluate Tolerability of midostaurin (30mg/m2 bid or 1 mg/kg bid for participants <10 kg body weight) in sequential combination with chemotherapy followed by 12 cycles of midostaurin post-consolidation therapy.
Secondary outcome measures
Part 1 and Part 2 of the study: Plasma concentrations of midostaurin and its metabolites
Part 2 of the study: Disease free survival (DFS)
Part 2 of the study: Event Free Survival (EFS)
+6 moreSide effects data
From 2021 Phase 3 trial • 301 Patients • NCT0337972719%
Nausea
13%
Neutropenia
9%
Diarrhoea
6%
Hypertension
6%
Alanine aminotransferase increased
6%
Thrombocytopenia
4%
Anaemia
3%
Rash
3%
Back pain
3%
Oedema peripheral
3%
Headache
3%
Platelet count decreased
3%
Pyrexia
3%
Arthralgia
3%
Vomiting
3%
Aspartate aminotransferase increased
2%
Constipation
2%
Asthenia
1%
Anxiety
1%
Hypotension
1%
Musculoskeletal chest pain
1%
Prostate cancer
1%
Abdominal pain
1%
Abdominal pain upper
1%
Large intestinal obstruction
1%
Insomnia
1%
Pain in extremity
1%
Cough
1%
Leukocytosis
1%
Oral herpes
1%
Pneumonia
1%
Electrocardiogram QT prolonged
1%
Hypokalaemia
1%
Subileus
1%
Endocarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Phaase
Induction Phase
Consolidation Phase
Overall
Trial Design
1Treatment groups
Experimental Treatment
Group I: Chemotherapy followed by MidostaurinExperimental Treatment6 Interventions
In Part 1, midostaurin with standard induction (Block 1 induction according to local practice, Block 2 induction containing fludarabine, cytarabine, daunorubicin/idarubicin) and consolidation (Block 3: cytarabine + mitoxantrone, Block 4: cytarabine + etoposide, Block 5: cytarabine) followed by single agent midostaurin post-consolidation therapy.
In Part 2, midostaurin with standard induction (Block 1 induction according to local practice, Block 2 induction containing cytarabine + mitoxantrone) and consolidation (Block 3: cytarabine + etoposide, Block 4: cytarabine + mitoxantrone, Block 5: cytarabine) followed by single agent midostaurin post-consolidation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midostaurin
2018
Completed Phase 3
~1640
Etoposide
2010
Completed Phase 3
~2440
Fludarabine
2012
Completed Phase 3
~1100
Cytarabine
2016
Completed Phase 3
~3310
Mitoxantrone
2008
Completed Phase 3
~1540
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a FLT3 inhibitor, but not for more than a week before joining this study.I have a new diagnosis of AML according to the latest standards.My lab tests show a FLT3 mutation.I do not have any other cancer types or specific leukemia conditions.My kidneys are working well enough (creatinine clearance ≥ 30 ml/min).My condition is a type of leukemia that affects areas outside the bone marrow, or I have secondary AML or MDS.I can care for myself but may need occasional help.My leukemia is of a specific type known as Acute Promyelocytic.I have symptoms from leukemia affecting my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy followed by Midostaurin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other medical studies have included Midostaurin as a potential treatment?
"There are 886 ongoing clinical trials that are studying midostaurin. 153 of those active trials are in their third and final phase. Most of the trials for Midostaurin are based in Seattle, Washington, but there 26551 locations running these medical studies."
Answered by AI
Could I join this research study?
"Patients between the ages of 3 months and 17 years old that have acute myeloid leukemia are eligible for this study. There is a total goal of 23 patients."
Answered by AI
Has the FDA given Midostaurin the green light?
"Midostaurin is still in the early stages of clinical research and, as such, has not yet been proven effective. However, there is data supporting its safety which earned it a score of 2."
Answered by AI
Can middle-aged adults enroll in this experiment?
"Children aged 3 months to 17 years old can participate in this clinical trial. Out of the 1272 trials for patients over 65, this is one of 460 studies accessible to minors."
Answered by AI
What are the common applications for Midostaurin?
"Midostaurin is mostly used to fight myeloblastic leukemia, but it can also be employed against gestational trophoblastic disease, neoplasms, and leptomeningeal metastases."
Answered by AI
Are investigators presently looking for participants in this research project?
"That is correct, the clinical trial indicated on clinicaltrials.gov is currently looking for 23 patients from 1 location(s). The trial was posted on 3/13/2019 and updated most recently on 9/15/2022."
Answered by AI
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