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Acute Myeloid LeukemiaPhase 1/2MOSAICNCT04385290

Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

A Phase 1/2 study testing MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO and MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 21 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO and MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
21 sitesGermany
Study dates
4 Sep 2020to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Newly diagnosed AML according to the criteria of the World Health Organisation plus the following molecular or cytogenetic specifications:
  • Phase I Trial - MODULE:
  • t(8;21)/RUNX1-RUNX1T1 or
  • inv(16) or t(16;16)/CBFB-MYH11 or
  • FLT3-ITD or
Show all 24Show fewer
  • FLT3-tyrosine kinase domain (FLT3-TKD)
  • Phase II Trial - MAGNOLIA
  • t(8;21)/RUNX1-RUNX1T1 or
  • inv(16) or t(16;16)/CBFB-MYH11
  • Phase II Trial - MAGMA
  • FLT3-ITD or
  • FLT3-TKD
  • Absence of mutations in CBF genes (i.e. t(8;21)/RUNX1-RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
  • Male and female patients aged
  • 18 - ≤ 75 years in Phase I Trial - MODULE
  • 18 - ≤ 70 years in Phase II Trials - MAGMA and MAGNOLIA
  • Eastern Cooperative Oncology Group (ECOG) Score of 0-2
  • Life expectancy > 14 days
  • Adequate hepatic and renal function
  • alanine aminotransferase / aspartate transaminase ≤ 2.5 x ULN
  • Bilirubin < 2 x upper limits of normal
  • Creatinine < 1.5 x upper limits of normal or Creatinine clearance > 40 ml/min
  • White blood cell count < 30 × 10^9/L. Note: Hydroxyurea and/or a dose of 100-200 mg/m^2 cytarabine per day for up to 3 days (for emergency use for clinical stabilization) is permitted to meet this criterion.

Who cannot join

  • Previous antineoplastic treatment for AML other than hydroxyurea and/or cytarabine for emergency use (100-200 mg/m^2 per day on maximal 3 days)
  • Previous treatment with anthracyclines
  • central nervous system involvement
  • Isolated extramedullary AML
  • Uncontrolled infection
  • AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
Show all 30Show fewer
  • Any investigational agent within 30 days or 5 half-lives, whichever is greater, prior to day 1. An investigational agent is defined as an agent with no approved medical use in adults or in pediatric patients
  • Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)
  • Strong CYP3A4/5 enzyme inducing drugs unless they can be discontinued or replaced prior to enrollment
  • Any other known disease or concurrent severe and/or uncontrolled medical condition (e.g., cardiovascular disease including congestive heart failure or active uncontrolled infection) that could compromise participation in the study
  • Impairment of gastrointestinal (GI) function or GI disease that might alter significantly the absorption of midostaurin
  • Confirmed diagnosis of HIV infection,
  • Active viral hepatitis unless serology demonstrates clearance of infection. Occult or prior hepatitis B virus (HBV) infection, defined as negative hepatitis B surface antigen and positive total hepatitis core antibodies, may be included if HBV DNA is undetectable, provided that patients are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody after vaccination or prior cured hepatitis B are eligible. Patients for hepatitis C virus (HCV) antibody are eligible provided PCR is negative for HCV RNA.
  • Cardiovascular abnormalities, including any of the following:
  • History of myocardial infarction, angina pectoris, Coronary Artery Bypass Grafting within 6 months prior to starting study treatment
  • Clinically uncontrolled cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II and third degree atrioventricular block)
  • Uncontrolled congestive heart failure
  • Left ventricular ejection fraction of < 50%
  • Poorly controlled arterial hypertension
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they fulfill at least one of the following criteria:
  • Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum follicule stimulating hormone > 40 U/ml)
  • Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days before the first dose of study drug
  • Continuous and correct application of a contraception method with a Pearl Index of < 1% (e.g. implants, depots, oral contraceptives, intrauterine device) from initial study drug administration until at least 7 months after the last dose of gemtuzumab ozogamicin and at least 4 months after the last dose of midostaurin, whichever period is longer. A hormonal contraception method must always be combined with a barrier method (e.g. condom)
  • Sexual abstinence
  • Vasectomy of the sexual partner
  • Sexually active males unless they use a condom during intercourse while taking the drug during treatment, and for at least 4 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via semen
  • Unwillingness or inability to comply with the protocol
  • Known hypersensitivity to midostaurin, GO, cytarabine or daunorubicin or to any of the excipients of midostaurin, GO, cytarabine or daunorubicin.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christoph Röllig, Prof. Dr. contact

+49 351 458 ext. 3775

MOSAIC@ukdd.de

Manja Reimann, Dr. contact

+49 351 458 ext. 3091

MOSAIC@ukdd.de

21 sites in 1 country

Germany21 sites, 21 recruiting

  • Universitätsklinikum Aachen

    Aachen, 52074

    Edgar Jost, Prof.

    Recruiting

  • Universitätsklinikum Augsburg

    Augsburg, 86156

    Christoph Schmid, Prof.

    Not yet recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

    Mathias Hänel, Prof.

    Recruiting

  • Universitätsklinikum Dresden

    Dresden, 01307

    Christoph Röllig, Prof.

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

    Maher Hanoun, PD Dr.

    Recruiting

  • Johann Wolfgang Goethe-Universität

    Frankfurt am Main, 60590

    Björn Steffen, Dr.

    Recruiting

  • Universitätsklinikum Halle

    Halle, 06120

    Christine Dierks, Prof.

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

    Tim Sauer, Dr.

    Recruiting

  • Universitätsklinikum Jena

    Jena, 07740

    Sebastian Scholl, Prof. Dr.

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

    Lars Fransecky, Dr.

    Recruiting

  • Gemeinschaftsklinikum Mittelrhein gGmbH

    Koblenz, 56068

    Dirk Niemann, Dr.

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103

    Madlen Jentzsch, PD Dr.

    Recruiting

  • Klinikum Mannheim gGmbH

    Mannheim, 68167

    Nadine Müller, Dr.

    Recruiting

  • Philipps-Universität Marburg Fachbereich Medizin

    Marburg, 35043

    Kristina Sohlbach, Dr.

    Recruiting

  • LMU Klinikum, Campus Großhadern

    München, Bavaria, 81377

    Veit Bücklein, Dr.

    Recruiting

  • Rotkreuzklinikum München gGmbH

    München, 80634

    Alexander Höllein, Prof. Dr.

    Recruiting

  • Universitätsklinikum Münster

    Münster, 48149

    Christoph Schliemann, Prof.

    Recruiting

  • Klinikum Nürnberg-Nord

    Nuremberg, 90419

    Kerstin Schäfer-Eckart, Dr.

    Not yet recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

    Nadia Maguire

    Recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

    Martin Kaufmann, Dr.

    Recruiting

  • Rems-Murr-Klinikum Winnenden

    Winnenden, 71364

    Markus Schaich, Prof. Dr.

    Recruiting

Other trials in Germany

About this study

Official title: MidOStaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.

Read the detailed description

Acute myeloid leukemia is a malignancy that is still fatal for the majority of patients. Besides age, the genetic configuration of AML blasts is one of the strongest prognostic factors. Patients with mutations in the core-binding factor (CBF) genes have the best prognosis, however a considerable proportion of 35-60% will eventually relapse. Mutation and overexpression of receptor tyrosinkinases (RTK) have been proposed as main reasons for relapse development or chemoresistance in CBF AMLs. RTKs like stem cell factor receptor (c-KIT) and FLT3 are of high clinical relevance as they mediate proliferation and differentiation of hematopoietic stem cells. There is evidence that c-Kit mutations and high levels of c-KIT in CBF-AML have adverse effects on survival endpoints indicating c-KIT as potential therapeutic target in this special AML population. Midostaurin can be considered a potent c-KIT inhibitor besides having multi-kinase inhibitory activity for several other kinases of documented or potential pathogenetic relevance for AML, most importantly mutated FLT3. The kinase inhibition ultimately leads to inhibition of proliferation, cell cycle arrest, and apoptosis. Previous studies with other c-KIT inhibitors such as dasatinib showed promising results with respect to survival end points in newly diagnosed CBF AML patients. Midostaurin is considered a more potent c-KIT inhibitor than dasatinib and may be able to potentiate the inhibitory effect on leukemic cell growth.

Another important therapeutical target in CBF AML is the sialic acid-binding immunoglobulin-like lectin (CD33) which is expressed on the majority of AML blasts. Gemtuzumab Ozogamicin (GO) is a therapeutic CD33 antibody linked to a strong cytostatic drug (calicheamicin) which causes apoptosis of cancer cells upon internalization. For the combination of GO and standard intensive chemotherapy, metaanalyses of randomized trials have shown that i) a low-dose fractionated administration results in the best tolerability, and ii) among AML subgroups, patients with CBF AML have the greatest benefit from GO in addition to standard therapy. Subgroup analyses within the ALFA-0701 (A Randomized Study of Gemtuzumab Ozogamicin With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia Aged of 50-70 Years Old) trial population showing beneficial effects of GO on overall survival, relapse-free survival and event-free survival in patients positive for FLT3 mutation as compared to those negative for FLT3 mutation. Subgroup analyses of the GO registration trial ALFA-0701 showed a significant clinical benefit of the patients displaying a mutation in the FLT3 gene compared to those without this mutation. In Addition, CBF AML patients with FLT3 mutations expressed particularly high levels of CD33 antigen and that CD33 antigen levels were positively correlated to the improved survival after GO treatment. Furthermore, recently published data of two paediatric populations with internal tandem mutation in the FLT3 gene showed reduced relapse rates in GO recipients compared to the control group only receiving standard chemotherapy. These results suggest that GO is a particularly beneficiary agent in FLT3 mutated patients who would currently receive midostaurin in addition to intensive chemotherapy as a standard of care. Hence, from a clinical point of view there is an unambiguous rationale supporting the combination of midostaurin and GO for treatment of AML in the two cytogenetic subgroups: CBF AML and FLT3 mutated AML.

GO has become the new treatment standard for patients with CBF AML. The hypothesized positive effect of midostaurin is likely but randomized proof is laking.

Midostaurin has become the new treatment standard for AML patients with mutations in the FLT3 gene. The positive effect of GO is shown in a post-hoc subgroup analysis of the ALFA-0701 trial, but prospective randomized proof is lacking.

Therefore, the proposed trial intends i) to explore and establish the safe combination of GO plus midostaurin (MODULE) and ii) to evaluate the effect of midostaurin versus no midostaurin added to standard AML chemotherapy plus GO in CBF AML (MAGNOLIA) and iii) to evaluate the effect of GO versus no GO added to standard AML chemotherapy plus midostaurin in FLT3 mutated AML (MAGMA).

Being tested
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
Keywords
AML, FLT3 mutation, CBF, midostaurin, gemtuzumab ozogamicin
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GODrug

    Also called Rydapt, Mylotarg

    Midostaurin (IMP) induction: 25 mg or 50 mg peroral BID, days 8 to 21 depending on assigned dose level

    GO (IMP) induction: 3 mg/m^2 i.v. max 4.5 mg, on day1, or on days 1, 4, or days 1, 4, 7 depending on assigned dose level

    Daunorubicin (DNR, non-IMP) induction: 60 mg/m^2/day i.v., days 1 to 3

    Cytarabine (AraC, non-IMP) induction: 200 mg/m^2/day cont. infusion, days 1 to 7

  • MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GODrug

    Also called Rydapt, Mylotarg

    Midostaurin (IMP):

    RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles;

    GO (IMP): 3 mg/m^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only

    Daunorubicin (DNR, non-IMP):

    60 mg/m^2 i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders

    Cytarabine (AraC, non-IMP):

    200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

  • MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GODrug

    Also called Mylotarg

    GO (IMP): 3 mg/m^2 i.v. max 4.5 mg on days 1, 4, 7; 1 induction cycle only

    Daunorubicin (DNR, non-IMP):

    60 mg/m^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders

    Cytarabine (AraC, non-IMP):

    200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

  • MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+MidostaurinDrug

    Also called Mylotarg, Rydapt

    Midostaurin (IMP):

    RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21, induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles;

    GO (IMP): 3 mg/m^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only

    Daunorubicin (DNR, non-IMP):

    60 mg/m^2/day i.v., days 1 to 3 of induction cycles 1-2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders

    Cytarabine (AraC, non-IMP):

    200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

  • MAGMA-trial: conventional chemotherapy (AraC+DNR)+MidostaurinDrug

    Also called Rydapt

    Midostaurin (IMP):

    RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles

    Daunorubicin (DNR, non-IMP):

    60 mg/m^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders

    Cytarabine (AraC, non-IMP):

    200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

Study groups in NCT04385290
Study groupRoleWhat they receive
MODULE trial: dose escalationExperimentalPhase I (Trial part MODULE): The treatment plan combines increasing doses levels of midostaurin (25/50 mg BID) and gemtuzumab ozogamicin (3 mg/m^2 i.v. max 4.5 mg on day(s) 1, (4, 7)) with 7+3 standard chemotherapy scheme using cytarabine (200 mg/m^2 cont. inf. i.v. on days 1 to 7) and daunorubicin (60 mg/m^2 i.v. on days 1 to 3).
Receives: Drug: MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO
MAGNOLIA-trial: conventional chemotherapy+GO and midostaurinExperimentalPhase II (Trial part MAGNOLIA): midostaurin (recommended phase II dose, RP2D) is combined with treatment standard (7+3 standard chemotherapy scheme using cytarabine 200 mg/m^2 cont. inf. i.v. and daunorubicin 60 mg/m^2 i.v.) plus GO (recommended phase II dose, RP2D) in CBF AML
Receives: Drug: MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO
MAGNOLIA-trial: conventional chemotherapy+GOActive comparatorPhase II (Trial part MAGNOLIA): treatment standard of CBF AML (7+3 standard chemotherapy scheme using cytarabine 200 mg/m^2 cont. inf. i.v. and daunorubicin 60 mg/m^2 i.v. plus GO (3 mg/m^2 i.v. max 4.5 mg) on days 1, 4, 7). No additional Midostaurin is given.
Receives: Drug: MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO
MAGMA-trial: conventional chemotherapy+midostaurin and GOExperimentalPhase II (Trial part MAGMA): GO (recommended phase II dose, RP2D) is combined with treatment standard (7+3 standard chemotherapy scheme using cytarabine 200 mg/m^2 cont. inf. i.v. and daunorubicin 60 mg/m^2 i.v.) plus Midostaurin (recommended phase II dose, RP2D) in FLT3 mutated AML
Receives: Drug: MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin
MAGMA-trial: conventional chemotherapy+midostaurinActive comparatorPhase II Trial (MAGMA): treatment standard of FLT3 mutated AML (7+3 standard chemotherapy scheme using cytarabine 200 mg/m^2 cont. inf. i.v. and daunorubicin 60 mg/m^2 i.v plus midostaurin). No additional GO is given.
Receives: Drug: MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of midostaurin and GO combination

    as measured by the number of dose limiting toxicities related to midostaurin or GO exposure.

    Measured: treatment day 8 until day 42 at the latest

  2. Event Free Survival (EFS)

    Time interval from date of randomization until either primary treatment failure or relapse or death, whichever occurs first.

    Measured: up to 3 years from enrolment

Secondary outcomes (6)

  1. CR/CRi rate

    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.

    Measured: after induction treatment, approx. 2 months

  2. Duration of remission

    Duration of remission is defined as time interval from date of CR/CRi until morphologic relapse.

    Measured: up to 3 years from enrolment

  3. Cumulative incidence of relapse

    Cumulative incidence of relapse is defined as the time interval from date of first CR/CRi until relapse.

    Measured: up to 3 years from enrolment

  4. Relapse-free survival

    Relapse-free survival is defined as the time interval from date of first CR/CRi until either morphologic relapse or death in remission.

    Measured: up to 3 years from enrolment

  5. Overall survival

    Overall survival is defined as time interval from date of randomization until death from any cause.

    Measured: up to 3 years from enrolment

  6. Early mortality rate

    Early mortality is defined as death from any reason within 30 days and 60 days from start of induction.

    Measured: 30 and 60 days after commencement of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start4 Sep 2020
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The phase I dose escalation trial (MODULE) will be conducted according to the 3+3 design. The phase II trial in CBF AML (MAGNOLIA) will be conducted in a open label and randomized manner. The phase II trial in FLT3 mutated AML (MAGMA) will be conducted in a open label and randomized manner.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04385290
Sponsor's protocol ID
TUD-MOSAIC-075
Acronym
MOSAIC
Status last verified
Sep 2025
First submitted
8 May 2020
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO and MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christoph Röllig, Prof. Dr. (+49 351 458 ext. 3775, MOSAIC@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of midostaurin and GO combination (time frame: treatment day 8 until day 42 at the latest). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04385290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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