Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576156
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2020-09-18
Brief Title:
A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis MF Who Have Not Responded to Janus Kinase JAK-Inhibitor Treatment
Sponsor:
Geron Corporation
Organization:
Geron Corporation
Study Overview
Official Title:
A Randomized Open-Label Phase 3 Study to Evaluate Imetelstat GRN163L Versus Best Available Therapy BAT in Patients with Intermediate-2 or High-risk Myelofibrosis MF Relapsed Refractory RR to Janus Kinase JAK Inhibitor
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis MF who are relapsedrefractory to Janus Kinase JAK-Inhibitor treatment
Detailed Description:
This is a multicenter study with 2 arms and will include 3 phases a screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment and the participants eligibility will be reviewed b treatment phase from randomization until study treatment imetelstat or BAT discontinuation and c post treatment follow-up phase that begins when the participant discontinues treatment and will continue until death lost to follow-up withdrawal of consent or study end whichever occurs first Participants will be randomized 21 into 2 Arms Arm A will receive imetelstat and Arm B will receive BAT
Participants who meet progressive disease criteria and discontinue BAT may crossover to receive imetelstat treatment after sponsors approval
Participants who meet progressive disease criteria and discontinue BAT may crossover to receive imetelstat treatment after sponsors approval
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 |
|---|---|---|---|
| 2020-003288-24 | EUDRACT_NUMBER | None | None |