Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT04980404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2021-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inqovi Maintenance Therapy in Myeloid Neoplasms
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase Ib Study of Oral Decitabine/Cedazuridine as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation for Patients With Myeloid Neoplasms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
This research is being done to see if the drug Inqov is effective in reducing the chance of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) relapsing after standard of care stem cell transplant.
* This research study involves the study drug Inqovi, which is a combination of the drugs decitabine and cedazuridine.
* This research study involves the study drug Inqovi, which is a combination of the drugs decitabine and cedazuridine.
Detailed Description:
This is a prospective, non-randomized, open-label, phase Ib study of oral Inqov-decitabine/cedazuridine, given as maintenance therapy following allogeneic hematopoietic cell transplantation for patients with myeloid neoplasms
The U.S. Food and Drug Administration (FDA) has approved Inqovi for myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) relapse but it has not been investigated in the post-transplant setting.
Inqovi is made up of the two study drugs decitabine and cedazuridine. Decitabine is believed to work by stopping cancer cells from growing and spreading. Cedazuridine is believed to work by slowing down how quickly the body breaks down decitabine, which normally breaks down too quickly to be effective.
The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits.
As the study is looking for the highest dose of Inqovi that can be administered safely without severe or unmanageable side effects not everyone will receive the same dose of the study drug. Dosage will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
Participants will receive study treatment for up to 12 months and will be followed for up to 24 months after starting the study drug.
It is expected that about 22 people will take part in this research study.
Taiho Oncology, Inc., a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.
The U.S. Food and Drug Administration (FDA) has approved Inqovi for myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) relapse but it has not been investigated in the post-transplant setting.
Inqovi is made up of the two study drugs decitabine and cedazuridine. Decitabine is believed to work by stopping cancer cells from growing and spreading. Cedazuridine is believed to work by slowing down how quickly the body breaks down decitabine, which normally breaks down too quickly to be effective.
The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits.
As the study is looking for the highest dose of Inqovi that can be administered safely without severe or unmanageable side effects not everyone will receive the same dose of the study drug. Dosage will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
Participants will receive study treatment for up to 12 months and will be followed for up to 24 months after starting the study drug.
It is expected that about 22 people will take part in this research study.
Taiho Oncology, Inc., a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: