NCT04980404

Inqovi Maintenance Therapy in Myeloid Neoplasms

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia
• Stem Cell Leukemia

Interventions

Type	Name	Description
DRUG	Inqovi	Tablet combination of drugs decitabine and cedazuridine, given orally.

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-08-24
• Completion: 2026-11-01
• First posted: 2021-07-28
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study