Trial · NCT04385290
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
NCT04385290, Phase 1, Phase 2, Recruiting, Technische Universität Dresden
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC). Trials, record NCT04385290. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04385290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
- NCT number
- NCT04385290
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 214 participants, estimated
- Lead sponsor
- Technische Universität Dresden
- Conditions
- Acute Myeloid Leukemia
- Interventions
MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO, MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO, MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin, MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin
- First posted
- 2020-05-12
- Last updated
- 2025-09-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of midostaurin and GO combination | treatment day 8 until day 42 at the latest | as measured by the number of dose limiting toxicities related to midostaurin or GO exposure. |
| Primary | Event Free Survival (EFS) | up to 3 years from enrolment | Time interval from date of randomization until either primary treatment failure or relapse or death, whichever occurs first. |
| Secondary | CR/CRi rate | after induction treatment, approx. 2 months | CR/CRi rate is defined as the proportion of patients, who achieved a morphologic complete remission or a complete remission with incomplete hematologic recovery (CR or CRi) during study participation. |
| Secondary | Duration of remission | up to 3 years from enrolment | Duration of remission is defined as time interval from date of CR/CRi until morphologic relapse. |
| Secondary | Cumulative incidence of relapse | up to 3 years from enrolment | Cumulative incidence of relapse is defined as the time interval from date of first CR/CRi until relapse. |
| Secondary | Relapse-free survival | up to 3 years from enrolment | Relapse-free survival is defined as the time interval from date of first CR/CRi until either morphologic relapse or death in remission. |
| Secondary | Overall survival | up to 3 years from enrolment | Overall survival is defined as time interval from date of randomization until death from any cause. |
| Secondary | Early mortality rate | 30 and 60 days after commencement of therapy | Early mortality is defined as death from any reason within 30 days and 60 days from start of induction. |
Source ClinicalTrials.gov
Outcomes0
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/NCT04385290
GET https://conductscience.org/api/trials/v1/NCT04385290/registered