Inqovi Maintenance Therapy in Myeloid Neoplasms

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    22
  • sponsor
    Massachusetts General Hospital
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Updated on 17 October 2021
See if I qualify
graft versus host disease
hla-a
chronic myelomonocytic leukemia
decitabine
cell transplantation
leukemia
myelomonocytic leukemia
antifungal agents

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.

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.

Details
Condition Bone marrow disorder, Bone Marrow Disorder, MYELODYSPLASTIC SYNDROME, cmml, myelodysplastic syndromes, Acute Undifferentiated Leukemia, myelodysplastic syndrome (mds), Stem Cell Leukemia, chronic myelomonocytic leukaemia, Preleukemia, Chronic myelomonocytic leukemia, Myelodysplastic Syndromes (MDS), Juvenile Myelomonocytic Leukemia
Treatment Inqovi
Clinical Study IdentifierNCT04980404
SponsorMassachusetts General Hospital
Last Modified on17 October 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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)
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/L
Platelets 50,000/L
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)

Exclusion Criteria

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
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