Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Midostaurin

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).

Patients received standard of care alone in the post SCT setting

Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.

Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.

Standard of Care

Brian Elliott, MD

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.

Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.

Overall survival was defined as the time from transplant to death due to any cause.

Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease

Unable to retrieve a sufficient amount of archived samples to perform an analysis therefore the study was not able to verify the FLT3-ITD mutation status

Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.

Novartis Pharmaceuticals

AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Standard of Care With Midostaurin

ALL Patients

Total

Age, Continuous

Sex: Female, Male

Caucasian

Black

Asian

Other

Race/Ethnicity, Customized

Body Mass Index

Study Director

6 months

12 months

18 months

Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis

Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis

24 months

Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis

Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis

Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

Insufficient amount of samples to perform analysis

FLT3-ITD Mutation Status Centrally in Archived Material From Diagnosis (if Available) Including Mutant:Wild Type Ratio.

Visit 2,Cycle1,Day 1

Visit 4,Cycle1, Day 15

Visit 5,Cycle2,Day 1

Visit 6,Cycle3,Day 1

Visit 7,Cycle4,Day 1

Visit 8,Cycle5,Day 1

Visit 9,Cycle6,Day 1

Visit 10,Cycle 7 Day 1

Visit 11,Cycle 8 Day 1

Visit 12,Cycle 9 Day 1

Visit 13,Cycle 10 Day 1

Visit 14,Cycle 11 Day 1

Visit 15,Cycle 12 Day 1

PKC412

Metabolite CGP52421

Metabolite CGP62221

number of samples available differed across time points

Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels

Total Deaths

Deaths on-treatment

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 51 months.

Clinical Database Population: all treated patients

All Collected Deaths

Treatment

Post Treatment Follow-up

Spots Global Cancer Trial Database for Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial