Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797780
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-03-11
Brief Title:
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
Sponsor:
Syros Pharmaceuticals
Organization:
Syros Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome SELECT MDS-1
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha RARA positive and newly diagnosed with higher-risk myelodysplastic syndrome HR-MDS and who have not received treatment for this diagnosis The primary goal of the study is to compare the complete remission rate between the two treatment arms
Detailed Description:
A subset of participants have MDS characterized by an overexpression of the RARA gene A blood test will be used to identify participants with RARA-positive MDS Assessment of the RARA biomarker for study eligibility will be done by collection of blood samples from potential study participants at the pre-screening visit and testing at a central laboratory Participants who meet eligibility requirements will be randomized 21 to receive either Tamibarotene plus azacitidine or placebo plus azacitidine
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 |
|---|---|---|---|
| 2020-004528-40 | EUDRACT_NUMBER | None | None |