Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05447663
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2022-06-28
Brief Title:
A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IbII Open Label Study of Siremadlin Monotherapy and in Combination With Donor Lymphocyte Infusion as a Treatment for Patients With Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplantation Who Are in Complete Remission But at High Risk for Relapse
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has been stopped following to strategic decision from the Sponsor Not based on any safety findings or safety concerns with siremadlin
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone and in combination with donor lymphocyte infusion DLI in adult participants with AML who are in remission following allogeneic stem cell transplantation allo-SCT but are at high risk for relapse based on the presence of pre-transplant risk factors
Detailed Description:
This is a Phase IbII single arm open label multi-center study of siremadlin as monotherapy and in combination with DLI in adult participants with AML who are in complete remission CR or CR with incomplete count recovery CRi post allo-SCT but are at high risk for relapse based on the presence of pre-transplant risk factors
The primary purpose of the study was to confirm the safe dose and schedule of siremadlin monotherapy and in combination with DLI The study is also designed to assess the preliminary efficacy in preventing hematologic relapse
The study was initially planned to enroll approximately 38 participants starting with a dose confirmation of siremadlin monotherapy part 1 to determine the siremadlin recommended dose followed by a treatment strategy of siremadlinDLI Part 2
After enrolling 8 participants at the starting dose 30 mgday on days 1-5 of a 28-day treatment cycle in part 1 Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program For that reason the enrollment in part 2 will not be open The Novartis decision was not driven by any safety concerns
In part 1 approximately 12 participants were planned to be enrolled in 2 cohorts starting dose 30 mgday on days 1-5 of a 28-day treatment cycle dose level 1 at 40 mgday and dose level -1 at 20 mgday and participants were planned to be treated for a maximum of 24 cycles
In part 2 participants were planned to follow a treatment strategy which contains three consecutive phases for a maximum of 24 cycles in total
A priming phase with siremadlin monotherapy at the recommended dose determined in Part 1 for at least 2 cycles Participants who are not eligible for the combination phase of siremadlinDLI may continue priming phase with siremadlin monotherapy
A combination phase of siremadlin in combination with DLI siremadlinDLI for participants who are eligible to receive DLI up to a total of 3 combination cycles
A maintenance phase with siremadlin monotherapy
The primary purpose of the study was to confirm the safe dose and schedule of siremadlin monotherapy and in combination with DLI The study is also designed to assess the preliminary efficacy in preventing hematologic relapse
The study was initially planned to enroll approximately 38 participants starting with a dose confirmation of siremadlin monotherapy part 1 to determine the siremadlin recommended dose followed by a treatment strategy of siremadlinDLI Part 2
After enrolling 8 participants at the starting dose 30 mgday on days 1-5 of a 28-day treatment cycle in part 1 Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program For that reason the enrollment in part 2 will not be open The Novartis decision was not driven by any safety concerns
In part 1 approximately 12 participants were planned to be enrolled in 2 cohorts starting dose 30 mgday on days 1-5 of a 28-day treatment cycle dose level 1 at 40 mgday and dose level -1 at 20 mgday and participants were planned to be treated for a maximum of 24 cycles
In part 2 participants were planned to follow a treatment strategy which contains three consecutive phases for a maximum of 24 cycles in total
A priming phase with siremadlin monotherapy at the recommended dose determined in Part 1 for at least 2 cycles Participants who are not eligible for the combination phase of siremadlinDLI may continue priming phase with siremadlin monotherapy
A combination phase of siremadlin in combination with DLI siremadlinDLI for participants who are eligible to receive DLI up to a total of 3 combination cycles
A maintenance phase with siremadlin monotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2021-003596-34 | EUDRACT_NUMBER | None | None |