Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant

Phase 2

Withdrawn

• Conditions: Acute Myeloid Leukemia With Gene Mutations; Adult Acute Myeloid Leukemia in Remission
• Interventions: Drug: Midostaurin

• Registration Number: NCT02723435
• Lead Sponsor: Stanford University

Brief Summary

This phase 2 trial studies the side effects and how well midostaurin works in treating older patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell transplantation. Midostaruin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving midostaruin post-transplant may improve patient outcomes.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the efficacy and safety of maintenance midostaurin (a fms related tyrosine kinase 3 \[FLT3\] inhibitor) for elderly patients with FLT3-internal tandem duplication (ITD)/tyrosine kinase domain (TKD) mutated acute myeloid leukemia (AML) who were previously enrolled on study HEMAML0022/CPKC412AUS27T and have then undergone allogeneic transplant.

SECONDARY OBJECTIVES:

I. To determine whether maintenance midostaurin after allogeneic transplant decreases the relapse rate in patients with FLT3-ITD/TKD mutated AML.

OUTLINE:

Beginning 30 days post-hematopoietic cell transplantation (HCT), patients receive midostaurin orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then up to 1 year.

Study Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-30
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midostaurin	Midostaurin	Beginning 30 days post-HCT, participants receive oral midostaurin twice-a-day in 28-day treatment cycles, continuing up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Event-free survival	Up to 1 year
Overall survival	Up to 1 year	Calculated and reported with Kaplan Meier curves. The statistical analyses will focus on estimation rather than hypothesis testing. Two-sided 95% confidence intervals will be presented, using the Clopper-Pearson method for proportions and using Greenwood's formula for time to event outcomes.
Incidence of adverse events using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	Up to 30 days
Relapse free survival	Up to 1 year	Calculated and reported with Kaplan Meier curves. The statistical analyses will focus on estimation rather than hypothesis testing. Two-sided 95% confidence intervals will be presented, using the Clopper-Pearson method for proportions and using Greenwood's formula for time to event outcomes.

Secondary Outcome Measures

Name	Time	Method
Relapse rate after allogeneic transplant	Up to 1 year	Described using proportions.