Inqovi Maintenance Therapy in Myeloid Neoplasms

NCT04980404 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 21-214
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelomonocytic Leukemia; Stem Cell Leukemia; Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; Stem Cell Leukemia

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Schedule Dose

  Identify the recommended phase II schedule of oral decitabine/cedazuridine through standard 3+3 Dose escalation model.

  42 Days

Secondary Outcomes (6)

• Median number of days of Inqovi tolerated

  Up to 2 years

• Cumulative incidence of acute GVHD

  Up to 2 years

• Cumulative incidence of significant chronic GVHD

  Up to 2 years

• Overall survival Rate

  The time from first dose of study drug to the date of death due to any cause up to 2 years

• Relapse-free survival Rate

  The time from first dose of study drug to the earlier of relapse or death due to any cause up to 2 years

Study Arms (2)

Dose Escalation Inqovi

EXPERIMENTAL

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

Drug: Inqovi

Recommended Phase 2 Dose Expansion (RP2S) Inqovi

EXPERIMENTAL

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.

Drug: Inqovi

Interventions

Inqovi DRUG

Tablet combination of drugs decitabine and cedazuridine, given orally.

Also known as: decitabine, cedazuridine

Dose Escalation Inqovi; Recommended Phase 2 Dose Expansion (RP2S) Inqovi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
• Subjects should have less than 5% myeloblasts on a bone marrow biopsy within 42 days prior to the start of conditioning.
• Age ≥ 18
• Will undergo first allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy.
• Transplantation will be performed with the use of reduced intensity conditioning (RIC).
• HSCT Donor will be one of the following:
• /6 or 6/6 (HLA-A, B, DR) matched related donor
• /8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level.
• Haploidentical related donor, defined as ≥ 3/6 (HLA-A, B, DR) matched
• ≥ 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4/6 matched with the recipient.
• ECOG performance status 0-2.
• 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)

You may not qualify if:

• Prior allogeneic hematopoietic stem cell transplants.
• History of other malignancy(ies) unless
• the participant has been disease-free for at least 12 months and is deemed by the investigator to be at low risk of recurrence of that malignancy, or
• the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin
• Known diagnosis of active hepatitis B or hepatitis C
• Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 50%, as measured by MUGA scan or echocardiogram)
• Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome
• Systemic uncontrolled infection
• Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally
• Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mmHg or diastolic BP \> 100 mmHg)
• QTc interval (i.e., Friderica's correction \[QTcF\]) ≥ 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• Breastfeeding women

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Taiho Oncology, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Biphenotypic, Acute

Interventions

decitabine and cedazuridine drug combination; Decitabine; cedazuridine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Zachariah DeFilipp, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 28, 2021
• Study Start: September 17, 2021
• Primary Completion: August 24, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)