Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03268954
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2017-08-30
Brief Title:
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes HR MDS Chronic Myelomonocytic Leukemia CMML or Low-Blast Acute Myelogenous Leukemia AML
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Randomized Controlled Open-label Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia or Low-Blast Acute Myelogenous Leukemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
PANTHER
Brief Summary:
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival EFS when compared with single-agent azacitidine An event is defined as death or transformation to AML in participants with MDS or CMML whichever occurs first and is defined as death in participants with low-blast AML
Detailed Description:
The drug being tested in this study is called pevonedistat Pevonedistat is being tested to treat people with higher-risk myelodysplastic syndromes HR MDS chronic myelomonocytic leukemia CMML and low-blast acute myelogenous leukemia 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 approximately 450 participants Once enrolled participants will be randomly assigned in 11 ratio 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 Spain Belgium Brazil Canada Czech Republic France Germany Israel Italy the United States Australia Greece Japan Mexico Poland Russia Korea Turkey China and United Kingdom The overall time to participate in this study is approximately 63 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 with HR MDS or CMML will have EFS follow-up study visits every month if their disease has not transformed to AML and they have not started subsequent therapy Participants with low-blast AML will have response follow-up study visits every month until they relapse from CR or meet the criteria for PD All participants will enter OS follow-up contacted every 3 months when they have confirmed transformation to AML for participants with HR MDS or CMML at enrollment or experienced PD for participants with low-blast AML at study enrollment
The study will enroll approximately 450 participants Once enrolled participants will be randomly assigned in 11 ratio 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 Spain Belgium Brazil Canada Czech Republic France Germany Israel Italy the United States Australia Greece Japan Mexico Poland Russia Korea Turkey China and United Kingdom The overall time to participate in this study is approximately 63 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 with HR MDS or CMML will have EFS follow-up study visits every month if their disease has not transformed to AML and they have not started subsequent therapy Participants with low-blast AML will have response follow-up study visits every month until they relapse from CR or meet the criteria for PD All participants will enter OS follow-up contacted every 3 months when they have confirmed transformation to AML for participants with HR MDS or CMML at enrollment or experienced PD for participants with low-blast AML at study enrollment
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 |
|---|---|---|---|
| 2017-000318-40 | EUDRACT_NUMBER | None | None |
| U1111-1189-8055 | OTHER | None | None |
| MOH_2018-02-04_002154 | OTHER | None | None |
| JapicCTI-183848 | REGISTRY | None | None |
| NCI-2017-02059 | OTHER | National Cancer Institute | None |