Inqovi Maintenance Therapy for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Trial Summary
What is the purpose of this trial?
This trial is testing Inqovi, a drug that combines decitabine and cedazuridine, to see if it can prevent relapse in patients with MDS or CMML after a stem cell transplant. Decitabine stops cancer cells from growing, and cedazuridine helps decitabine stay effective longer. The study aims to find the safest dose for these patients. Decitabine has shown effectiveness in various blood-related cancers.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Inqovi (Decitabine-Cedazuridine) for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia?
Inqovi, a combination of decitabine and cedazuridine, has been shown to be effective for treating Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) in clinical trials. Studies demonstrated that the drug's effectiveness is similar to intravenous decitabine, with a complete remission rate of around 21% and a median remission duration of 7.5 to 8.7 months.12345
Is Inqovi (Decitabine-Cedazuridine) safe for humans?
Inqovi, a combination of decitabine and cedazuridine, has been studied for safety in humans, showing similar safety profiles to intravenous decitabine. Common serious side effects include low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and fever with low white blood cell counts (febrile neutropenia).12346
How is the drug Inqovi different from other treatments for myelodysplastic syndrome and chronic myelomonocytic leukemia?
Inqovi is unique because it combines decitabine, a drug that modifies DNA to stop cancer cell growth, with cedazuridine, which helps the body absorb decitabine when taken orally. This allows patients to take the treatment as a pill instead of needing intravenous infusions, making it more convenient.12346
Research Team
Zachariah DeFilipp, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for adults with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) who are undergoing their first stem cell transplant. They must have a matched donor, good organ function, and no severe heart issues or infections. Women of childbearing age need a negative pregnancy test and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Initial group of 3 participants will receive Inqovi on days 1-3 of a 42 day cycle to determine dose-limiting toxicity
Recommended Phase 2 Dose Expansion
Once the Recommended Phase 2 Dose Expansion is established, 10 additional participants will receive Inqovi on days 1-3 of a 28 day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inqovi
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Taiho Oncology, Inc.
Industry Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD