Trial · NCT03591510
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
NCT03591510, Phase 2, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML. Trials, record NCT03591510. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03591510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
- NCT number
- NCT03591510
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- FLT3-mutated Acute Myeloid Leukemia
- Interventions
- Midostaurin, Fludarabine, Cytarabine, Daunorubicin or idarubicin, Mitoxantrone, Etoposide
- First posted
- 2018-07-19
- Last updated
- 2026-07-09
- Other registries' IDs
- eudract:2017-004830-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 of the study: Occurence of dose limiting toxicities (DLT) | From the start of midostaurin treatment in Block 1 to the end of Block 2, from Day 1 to Day 84 | Dose-limiting toxicity (DLT) is defined as any death due to toxicity related to study treatment (chemotherapy + midostaurin) and/or any CTCAE grade 4 non-hematological adverse event or abnormal laboratory value grade 4 related to study treatment unless the event improves sufficiently by day 42 and therefore does not further delay the next cycle of study treatment. |
| Primary | 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. | From the start of treatment up to 5 years follow-up of last patient | Safety profile includes type, frequency and severity of adverse events during the induction, consolidation and post consolidation phase. AEs are also collected during post treatment follow-up phase |
| Primary | 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. | From the start of treatment up to 5 years follow-up of last patient | Number of dose interruptions/reductions and discontinuations due to study drug |
| Secondary | Part 2 of the study: Percentage of participants with response (CR, CR/modified CRi and CR/CRi) | From the start of treatment in Block 1 to the end of Block 2, from Day 1 up to Day 84 | Percentage of participants with a response of CR, CRi or modified CRi at the end of Block 2 |
| Secondary | Part 2 of the study: Time to response (TTR) and response duration | From the start of treatment up to 5 years follow-up of last patient | TTR is defined as the time between start of treatment to the date of first onset of response (CR, CRi or modified CRi). Response duration is defined as the time from CR, CRi or modified CRi to relapse or death due to any cause. |
| Secondary | Part 2 of the study: Event Free Survival (EFS) | From the start of treatment to time when all patients have completed at least 18 months of follow up (~ 48 months) | EFS is defined as the time from Day 1 of chemotherapy until an EFS event is observed. An EFS event is defined as a failure to obtain CR/Modified CRi within induction, relapse after CR/modified CRi, or death due to any cause, whichever occurs first. EFS will be measured after all participants completed at least 18 months of follow-up. |
| Secondary | Part 2 of the study: Overall Survival (OS) | At each visit, every 3 months after last follow-up visit and up to 5 years after last patient first treatment | OS is defined as the time from Day 1 of chemotherapy to the date of death due to any cause. |
| Secondary | Part 2 of the study: Disease free survival (DFS) | From the start of treatment up to 5 years follow-up of last patient | DFS is defined as the time from CR/modified CRi in induction to relapse or death due to any cause |
| Secondary | Part 2 of the study: Percentage of participants with MRD negative status during each study phase | MRD is evaluated at Day 14 after end of chemotherapy induction Block 1, at Day 21 of Blocks 2, 3, 4 and 5, and Cycle 7 during post-consolidation phase (each block could last up to 42 days) | Percentage of patient with MRD negative status by multiparameter flow cytometry |
| Secondary | Part 2 of the study: Palatability of oral solution of midostaurin | Day 14 after end of chemotherapy induction Block 1, Day 21 of Blocks 2, 3, 4 and 5 (each block can last up to 42 days), post-consolidation Cycle 1, Cycle 3, Cycle 5, Cycle 7, Cycle 9, Cycle 11 | Palatability is assessed through questionnaires- Palatability PRO and obsPRO |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03591510
GET https://conductscience.org/api/trials/v1/NCT03591510/registered