A Phase 2 interventional study of Midostaurin and Cytarabine in Acute Myeloid Leukemia, sponsored by University of Ulm. Completed at 55 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Ulm · Phase 2, Interventional, and Treatment
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.
The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
Sample size: 440 patients
The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance and follow-up period: Maximum 8 years
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's enrollment of 451 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
•AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
Drug: Midostaurin · Drug: Cytarabine · Drug: Daunorubicin
Induction therapy: 50 mg, oral, twice daily, starting on day 8, thereafter continuous dosing until 48h before start of subsequent chemotherapy cycle. Consolidation therapy: 50 mg, oral twice daily, starting on day 6, thereafter continuous dosing until 48h before start of conditioning therapy for allogeneic HSCT or 48h before start of subsequent consolidation chemotherapy. Maintenance therapy: 50 mg oral twice daily over one year.
Also known as: PKC412
Induction therapy: 200 mg/m2/day by continuous i.v. infusion on days 1-7 (total dose 1400 mg/m²) Consolidation therapy: Younger adult patients (18 to 65 yrs): 3 g/m2 by i.v infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 18 g/m2). Older patients (\>65 yrs): 1 g/m2 by i.v. infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 6 g/m2).
Induction therapy: 60 mg/m², by 1-hour i.v. infusion, day 1-3 (total dose 180 mg/m²)
Event-free Survival
To perform two predefined subgroup analyses in the age-groups 18-60 years and 61-70 years evaluating the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
Time frame: 8years
Rate of complete remission (CR)
Time frame: Two months
Relapse-free survival
Time frame: 8 years
overall survival
Time frame: 8 years
Cumulative incidence of relapse
Time frame: 8 years
cumulative incidence of death in CR
Time frame: 8 years
Target (FLT3) inhibition by measuring the FLT3 plasma inhibitory activity
Evaluation of target (FLT3) inhibition by continuous dosing of midostaurin
Time frame: 8 years
Quality of life
Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics initially, in first CR, after one year,3 and 5 years after initial diagnosis.
Time frame: 5 years
Rate of early deaths and hypoplastic deaths (ED/HD)
Time frame: two months
Death in CR
Time frame: 8 years
Toxicities
Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 3.0), timing and relatedness of hematological and non-hematological toxicities observed during the different treatment cycles
Time frame: between 18 and 24 months
Impact of allogeneic HSCT
Assessment of the relative impact of allogeneic HSCT analyzed as time-dependent variable on survival endpoints.
Time frame: 8 years
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midostaurin