Trial · NCT03591510
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Part 2 of the study: Percentage of blasts in bone marrow and peripheral blood | Parameters are assessed 14 days after end of chemotherapy induction Block 1 and Day 14 induction Block 2 | Bone marrow and peripheral blood parameters and extramedullar involvement at the end of induction Block 1 and Block 2 |
| Secondary | Part 1 and Part 2 of the study: Plasma concentrations of midostaurin and its metabolites | Days 1, 7 & 14 after end of local chemotherapy-induction in Block 1, Days 14 & 21 of Block 2, Day 21 of Blocks 3, 4 & 5 (each block can last up to 42 days), in-post consolidation Day 1 of Cycle (C)2, C3, C5, C7, C9 and C12 (each cycle = 28 days) | Plasma concentration of midostaurin and its 2 metabolites |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03591510/registered