Symptoms and General Pathology

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All Drugs and Chemicals

Decitabine

Antimetabolites

Enzyme Inhibitors

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

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.

Tablet combination of drugs decitabine and cedazuridine, given orally.

Inqovi

Zachariah DeFilipp, MD

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.

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.

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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

Median number of day of Inqovi tolerated tabulated and reported descriptively.

Cumulative incidence of acute GVHD tabulated and reported descriptively.

Cumulative incidence of significant chronic GVHD tabulated and reported descriptively.

Proportion of subjects who successfully screen for study prior to transplantation but who do not reach the maintenance phase due to transplant related morbidity or mortality tabulated and reported descriptively.

Taiho Oncology, Inc.

Massachusetts General Hospital

Principal Investigator

Immune System Diseases

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasm, Residual

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplastic Processes

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Blinatumomab

Immunosuppressive Agents

Eligible patients with detectable MRD will taper immunosuppressive medications, if applicable, and undergo treatment with blinatumomab. The duration of each cycle of blinatumomab treatment is 6 weeks. Adult and pediatric patients will be treated for 4 weeks followed by a 2-week treatment free period. Patients may receive up to 4 cycles total of blinatumomab therapy.

blinatumomab

David Sanford, MD

This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. MRD testing phase and 2. blinatumomab treatment phase. Participants with B-ALL planning for HSCT meeting other eligibility criteria will be enrolled onto the MRD testing phase, which will involve centralized MRD testing of bone marrow aspirate samples on day +56, +100, +180, +270 following HSCT. Participants with detectable MRD ≥10\^-4 leukemic cells/total nucleated cells will enroll onto the treatment phase. Blinatumomab treatment will be started following detection of MRD after 7 to 42 days from enrollment onto the treatment phase to allow for initiation of taper of immunosuppressive medications.

Participants will be monitored for MRD post transplant during the testing phase of the trial. If they have detectable MRD, they will be enrolled into the blinatumomab treatment phase.

Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial

To determine the proportion of patients with MRD response, defined as negative MRD as measured by flow cytometry, after 1 cycle of blinatumomab.

Safety of delivering blinatumomab will be monitored early during the post-transplant course. Safety will be evaluated by the onset of treatment emergent adverse events (TEAEs) and by documentation of the incidence and severity of acute and chronic graft versus host disease (GvHD).

Clinically relevant survival outcomes for patients enrolled onto the study including: 2-year and 5-year overall survival (OS) and event free-survival (EFS) and median OS.

To determine the proportion of patients developing detectable MRD following HSCT for B-ALL as measured by flow cytometry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inqovi Maintenance Therapy in Myeloid Neoplasms	NCT04980404	Myelodysplastic... Chronic Myelomo... Stem Cell Leuke...	Inqovi	18 Years -	Massachusetts General Hospital
Inqovi Maintenance Therapy in Myeloid Neoplasms	NCT04980404	Myelodysplastic... Chronic Myelomo... Stem Cell Leuke...	Inqovi	18 Years -	Massachusetts General Hospital
Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant	NCT04044560	B-cell Adult Ac... Stem Cell Leuke... Minimal Residua...	blinatumomab	1 Year -	University of British Columbia

Spots Global Cancer Trial Database for stem cell leukemia