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Inqovi Maintenance Therapy for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

Phase 1
Recruiting
Led By Zachariah DeFilipp, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have normal organ and function as defined below: AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional upper limit of normal (ULN), Total bilirubin < 1.5 x ULN (with the exception of subjects with a history of Gilbert's syndrome), Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula), LVEF must be equal to or greater than 50%, as measured by MUGA scan or echocardiogram, Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing, The effects of decitabine/cedazuridine on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment, Ability to understand and the willingness to sign a written informed consent document
Eligibility Criteria Prior to Treatment (Post HCT): Maintenance therapy may begin at any time between day 30 and day 120 following hematopoietic cell transplantation. Participants must meet the following criteria to be eligible to treatment on this study: Chimerism studies reveal that ≥ 70% of blood or bone marrow cells, or of the CD33 expressing fraction, are of donor origin, There is no acute graft versus host disease (GVHD), requiring an escalation of corticosteroid dose or addition of other agent in the 4 weeks prior to Cycle 1 Day 1, There is no morphological evidence of relapsed/recurrent/residual disease (as assessed by post HCT bone marrow biopsy and aspirate), There is no systemic infection requiring IV antibiotic or antifungal or antiviral therapy within 7 days of starting decitabine/cedazuridine, ANC ≥ 1000/µL, Platelets ≥ 50,000/µL, AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional upper limit of normal (ULN), Total bilirubin < 1.5 x ULN (with the exception of subjects with a history of Gilbert's syndrome), Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
Must not have
Systemic uncontrolled infection
Known diagnosis of active hepatitis B or hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The trial tests Inqovi as maintenance therapy post-stem cell transplant to prevent MDS/CMML relapse. Inqovi combines decitabine and cedazuridine, aiming to reduce the chance of disease returning after standard treatment.
What are the potential side effects?
Inqovi may cause side effects like nausea, vomiting, diarrhea, constipation, fatigue, joint pain, low blood counts leading to increased infection risk or bleeding problems. It can also affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for my first stem cell transplant from a donor.
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My bone marrow transplant donor matches me closely.
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I am able to care for myself and perform daily activities.
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My latest bone marrow test shows less than 5% myeloblasts.
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I have been diagnosed with MDS or CMML.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any untreated infections.
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I have an active hepatitis B or C infection.
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I do not have severe heart failure or a history of poor heart function.
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I have had a stem cell transplant from a donor.
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I have a condition that affects my ability to swallow or absorb pills.
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I have or had serious heart rhythm problems or long-QT syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended Phase 2 Schedule Dose
Secondary study objectives
Cumulative incidence of acute GVHD
Cumulative incidence of significant chronic GVHD
Median number of days of Inqovi tolerated
+3 more

Side effects data

From 2022 Phase 2 trial • 14 Patients • NCT04055844
57%
Febrile neutropenia
57%
Neutrophil count decreased
21%
Infections and infestations - Other, specify
21%
Sepsis
21%
Lung infection
21%
Bacteremia
14%
Alanine aminotransferase increased
14%
Aspartate aminotransferase increased
14%
Infections and infestations - Other,
7%
Pericardial effusion
7%
INR increased
7%
Intracranial hemorrhage
7%
Sinusitis
7%
Blood and lymphatic system
7%
Upper gastrointestinal
7%
Tooth infection
7%
Hepatic infection
7%
Blood and lymphatic system disorders - Other, specify
7%
Typhlitis
7%
Alanine aminotransferase
7%
Fatigue
7%
General disorders and administration
7%
Disease progression
7%
General disorders and administration site conditions - Other, specify
7%
Syncope
7%
Hepatobiliary disorders
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
Gastrointestinal disorders - Other,
7%
Injury, poisoning and procedural
7%
Neoplasms benign, malignant and
7%
Hypertension
7%
White blood cell decreased
7%
Mucositis oral
7%
Upper gastrointestinal hemorrhage
7%
Fever
7%
Encephalopathy
7%
Hepatic failure
7%
Hyperglycemia
7%
Gastrointestinal disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Decitabine + Ruxolitinib + DLI

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Recommended Phase 2 Dose Expansion (RP2S) InqoviExperimental Treatment1 Intervention
Once the Recommended Phase 2 Dose Expansion (RP2S) is established, 10 additional participants will be enrolled and receive Inqovi (decitabine/cedazuridine) on days 1-3 of a 28 day study cycle.
Group II: Dose Escalation InqoviExperimental Treatment1 Intervention
Study will follow a standard '3+3' dose escalation design: * Initial group of 3 participants will receive Inqovi (decitabine/cedazuridine) on days 1-3 of a 42 day cycle/dose-limiting toxicity (DLT) period. * Additional enrollment, dosage and study cyles will be determined by number of dose-limiting toxicity (DLT) that occur in initial group

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myelodysplastic Syndrome (MDS) include hypomethylating agents (HMAs) such as decitabine and azacitidine. These drugs inhibit DNA methyltransferase, leading to the hypomethylation of DNA, which can reactivate tumor suppressor genes and promote the differentiation or apoptosis of abnormal hematopoietic cells. Cedazuridine, often combined with decitabine, inhibits cytidine deaminase, an enzyme that degrades decitabine, thereby increasing its bioavailability and effectiveness. These mechanisms are important for MDS patients as they address the epigenetic abnormalities driving the disease, potentially improving blood counts and reducing the risk of progression to acute myeloid leukemia (AML).

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,260 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
78 Previous Clinical Trials
13,071 Total Patients Enrolled
Zachariah DeFilipp, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
148 Total Patients Enrolled

Media Library

Inqovi Clinical Trial Eligibility Overview. Trial Name: NCT04980404 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Recommended Phase 2 Dose Expansion (RP2S) Inqovi, Dose Escalation Inqovi
Myelodysplastic Syndrome Clinical Trial 2023: Inqovi Highlights & Side Effects. Trial Name: NCT04980404 — Phase 1
Inqovi 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980404 — Phase 1
~5 spots leftby Nov 2025