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New treatment option for Acute Myeloid Leukemia
Official title Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
ClinicalTrials.gov ID: NCT04385290
What this study is testing
What is MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO?
MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Rydapt, Mylotarg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- (all study parts):
- 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
See the full eligibility criteria
- 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
- 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 \ 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.
- (all study parts):
- 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- München, Bavaria, Germany
- Essen, North Rhine-Westphalia, Germany
- Aachen, Germany
- Augsburg, Germany
- Chemnitz, Germany
- Dresden, Germany
- Frankfurt am Main, Germany
- Halle, Germany
- Heidelberg, Germany
- Jena, Germany
- Kiel, Germany
- Koblenz, Germany
- Leipzig, Germany
- Mannheim, Germany
- Marburg, Germany
- München, Germany
- Münster, Germany
- Nuremberg, Germany
- Regensburg, Germany
- Stuttgart, Germany
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include München, Bavaria, Germany; Essen, North Rhine-Westphalia, Germany; Aachen, Germany; Augsburg, Germany; Chemnitz, Germany; Dresden, Germany and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.