Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04097470
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-06
First Post:
2019-03-25
Brief Title:
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Organization:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Overview
Official Title:
A Randomized Phase II Multicenter Study to Assess the Tolerability and Efficacy of the Addition of Midostaurin to 10-day Decitabine Treatment in Unfit Adult Acute Myeloid Leukemia and High Risk Myelodysplasia Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HO155
Brief Summary:
The aim of this study is to investigate how safe and effective the addition of the new medicine midostaurin to decitabine is for the treatment of unfit acute myeloid leukemia AML and high-risk myelodysplasia MDS patients Patients who are ineligible for intensive chemotherapy because of accompanying diseases may opt for gentler treatment This does not produce a cure but serves to allow the quality of life to be acceptable for as long as possible Decitabine is an example of a gentler treatment It is effective against leukemia and has fewer side effects than intensive chemotherapy Given in courses of 5 successive days decitabine is registered for the treatment of AML There is scientific research to suggest that decitabine is more effective and generally well tolerated when given in courses of 10 successive days Therefore treatment with 10-day courses of decitabine is the standard treatment in this scientific research The aim is to investigate whether this standard treatment can be improved by adding a new product midostaurin Midostaurin is a medicine that is directed against a specific protein on leukaemia cells FLT3
Detailed Description:
This trial aims to develop effective treatments for unfit ie Hematopoietic cell transplantation co-morbidity index HCT-CI 3 in adult 18 yrs AML patients for whom current treatment strategies are highly unsatisfactory Therefore new treatment modalities are introduced and evaluated in multiple parallel randomized phase II studies that will be conducted within the frame of a master protocol The scheme of this new design consists of one arm with one of the currently considered best available treatments for unfit AML patients ie 10-day decitabine After a maximum of 3 10-day courses or less in case of good response treatment will be continued with 5-day decitabine courses This treatment will be compared to investigational treatments in combination with decitabine
The competitor of the 10-day decitabine schedule will be 10-day decitabine combined sequential with the tyrosine kinase inhibitor midostaurin independent of the presence of FLT3 mutations The rationale for midostaurin is 1 single agent midostaurin has shown efficacy in both FLT3 wild type and mutant AML 2 it has shown efficacy in a phase III randomized controlled trial when combined with intensive chemotherapy in FLT3-mutated AML RATIFY study 3 midostaurin has been successfully combined with hypomethylating agents azacitidine and decitabine and improved the response compared with historical response rates of these drugs suggesting at least additive affects of midostaurin with hypomethylating agents
The competitor of the 10-day decitabine schedule will be 10-day decitabine combined sequential with the tyrosine kinase inhibitor midostaurin independent of the presence of FLT3 mutations The rationale for midostaurin is 1 single agent midostaurin has shown efficacy in both FLT3 wild type and mutant AML 2 it has shown efficacy in a phase III randomized controlled trial when combined with intensive chemotherapy in FLT3-mutated AML RATIFY study 3 midostaurin has been successfully combined with hypomethylating agents azacitidine and decitabine and improved the response compared with historical response rates of these drugs suggesting at least additive affects of midostaurin with hypomethylating agents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL6463204218 | OTHER | CCMO | None |
| 2018-000047-31 | EUDRACT_NUMBER | None | None |
| 2018-674 | OTHER | None | None |