Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02610777
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2015-11-18
Brief Title:
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes HR MDS Chronic Myelomonocytic Leukemia CMML and Low-Blast Acute Myelogenous Leukemia AML
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Takeda
Study Overview
Official Title:
A Phase 2 Randomized Controlled Open-Label Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML or low-blast AML
Detailed Description:
The drug being tested in this study is called pevonedistat Pevonedistat is being tested to treat people with MDS or CMML or low-blast AML as a combination treatment with azacitidine This study will look at the overall survival event free survival and response to treatment in people who take pevonedistat and azacitidine when compared to people who take single-agent azacitidine
The study will enroll 120 participants Once enrolled participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups in 28-day treatment cycles
Pevonedistat 20 mgm2 and azacitidine 75 mgm2 combination
Single-agent azacitidine 75 mgm2
All participants will receive azacitidine via intravenous or subcutaneous route Participants randomized to the combination arm will also receive pevonedistat intravenous infusion
This multi-center trial will be conducted worldwide The overall time to participate in this study is approximately 44 months Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner Participants will enter event-free survival follow-up or response follow-up study visits every 3 months if their disease has not transformed to AML for participants with HR MDS or CMML or progressed for participants with low-blast AML and they have not started subsequent therapy Participants will also enter overall survival follow-up contacted every 3 months to document subsequent therapies and survival status
The study will enroll 120 participants Once enrolled participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups in 28-day treatment cycles
Pevonedistat 20 mgm2 and azacitidine 75 mgm2 combination
Single-agent azacitidine 75 mgm2
All participants will receive azacitidine via intravenous or subcutaneous route Participants randomized to the combination arm will also receive pevonedistat intravenous infusion
This multi-center trial will be conducted worldwide The overall time to participate in this study is approximately 44 months Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner Participants will enter event-free survival follow-up or response follow-up study visits every 3 months if their disease has not transformed to AML for participants with HR MDS or CMML or progressed for participants with low-blast AML and they have not started subsequent therapy Participants will also enter overall survival follow-up contacted every 3 months to document subsequent therapies and survival status
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 |
|---|---|---|---|
| Pevonedistat-2001CTID | OTHER | Israel | None |
| U1111-1169-6540 | REGISTRY | None | None |
| 2015-000221-37 | EUDRACT_NUMBER | None | None |
| REec-2016-2145 | REGISTRY | None | None |