RECRUITING

DEC-C and Thioguanine for R/R AML

Conditions

Acute Myeloid Leukemia Myeloid Neoplasm Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe.

Official Title

A Phase II Open-Label, Single Center Trial of Oral Decitabine-Cedazuridine (DEC-C) (Inqovi®) in Combination With Thioguanine (Tabloid®) in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

Quick Facts

Study Start:2024-01-30

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06351306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years of age 2. Patients must have histologically and cytologically confirmed R/R AML according to the World Health Organization classification based on documented bone marrow biopsy or peripheral blood specimens, with the exception of acute promyelocytic leukemia 1. Relapsed AML is defined as the detection of ≥5% blasts in the bone marrow or reappearance of leukemic blasts in the peripheral blood in a patient with prior remission 2. Refractory AML is defined as the failure to obtain a CR, CRh, or CRi after at least two courses of intensive induction (including hypomethylating agent plus venetoclax induction) or at least six cycles of a hypomethylating agent-based regimen (except venetoclax combinations as above) 3. Able to provide informed consent 4. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 or Karnofsky ≥60% 5. Adequate organ function defined by the following parameters: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5x the upper limit of normal (ULN) 2. Bilirubin ≤2x the ULN unless due to known Gilbert's disease or hemolysis due to blood transfusion 3. Calculated glomerular filtration rate (GFR) of ≥ 30 mL/min/1.73 m2 6. Prior hypomethylating agent is allowed 7. Female patients of childbearing potential must not be nursing or planning to become pregnant and require a negative urine or serum pregnancy test within 30 days of study therapy. 8. Female patients of childbearing potential must be willing to use at least 1 method of highly effective contraception during the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 9. Male patients treated or enrolled who are sexually active must agree to adequate contraception use and refrain from sperm donation throughout the duration of the study, and up to 4 months after completion of thioguanine and decitabine-cedazuridine. 10. Willing to provide pretreatment bone marrow aspirate and biopsies samples as well as subsequent bone marrow aspirate and biopsies samples during the study. 11. Ability to understand and the willingness to sign a written informed consent document.	1. Previously received thioguanine 2. Any anti-leukemic therapy, including investigational therapies, within 14 days of study treatment initiation. Hydroxyurea for blood count control is allowed throughout induction cycle(s) 3. Prior allogeneic hematopoietic stem cell transplantation within 3 months of study enrollment; active graft versus host disease 4. Clinical suspicion for active central nervous system (CNS) involvement by AML; previously treated CNS involvement is allowed 5. Second malignancy requiring treatment within 6 months of study enrollment, with the exception of non-melanoma skin cancers or cancers requiring hormonal therapy only 6. Active, uncontrolled infection 7. Human immunodeficiency virus (HIV) not controlled by standard therapy 8. Active hepatitis B or C infection. Participants whose infections are controlled with antiviral therapy are allowed. 9. Significant medical diseases or comorbidities, in the opinion of the investigator, that would preclude the safe participation in the study 10. Known hypersensitivity to DEC-C or thioguanine

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years of age
2. Patients must have histologically and cytologically confirmed R/R AML according to the World Health Organization classification based on documented bone marrow biopsy or peripheral blood specimens, with the exception of acute promyelocytic leukemia
1. Relapsed AML is defined as the detection of ≥5% blasts in the bone marrow or reappearance of leukemic blasts in the peripheral blood in a patient with prior remission
2. Refractory AML is defined as the failure to obtain a CR, CRh, or CRi after at least two courses of intensive induction (including hypomethylating agent plus venetoclax induction) or at least six cycles of a hypomethylating agent-based regimen (except venetoclax combinations as above)
3. Able to provide informed consent
4. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 or Karnofsky ≥60%
5. Adequate organ function defined by the following parameters:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5x the upper limit of normal (ULN)
2. Bilirubin ≤2x the ULN unless due to known Gilbert's disease or hemolysis due to blood transfusion
3. Calculated glomerular filtration rate (GFR) of ≥ 30 mL/min/1.73 m2
6. Prior hypomethylating agent is allowed
7. Female patients of childbearing potential must not be nursing or planning to become pregnant and require a negative urine or serum pregnancy test within 30 days of study therapy.
8. Female patients of childbearing potential must be willing to use at least 1 method of highly effective contraception during the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
9. Male patients treated or enrolled who are sexually active must agree to adequate contraception use and refrain from sperm donation throughout the duration of the study, and up to 4 months after completion of thioguanine and decitabine-cedazuridine.
10. Willing to provide pretreatment bone marrow aspirate and biopsies samples as well as subsequent bone marrow aspirate and biopsies samples during the study.
11. Ability to understand and the willingness to sign a written informed consent document.

1. Previously received thioguanine
2. Any anti-leukemic therapy, including investigational therapies, within 14 days of study treatment initiation. Hydroxyurea for blood count control is allowed throughout induction cycle(s)
3. Prior allogeneic hematopoietic stem cell transplantation within 3 months of study enrollment; active graft versus host disease
4. Clinical suspicion for active central nervous system (CNS) involvement by AML; previously treated CNS involvement is allowed
5. Second malignancy requiring treatment within 6 months of study enrollment, with the exception of non-melanoma skin cancers or cancers requiring hormonal therapy only
6. Active, uncontrolled infection
7. Human immunodeficiency virus (HIV) not controlled by standard therapy
8. Active hepatitis B or C infection. Participants whose infections are controlled with antiviral therapy are allowed.
9. Significant medical diseases or comorbidities, in the opinion of the investigator, that would preclude the safe participation in the study
10. Known hypersensitivity to DEC-C or thioguanine

Contacts and Locations

Study Contact

Research Nurse Navigator

CONTACT

212-342-5162

cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Joseph G. Jurcic, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Joseph Jurcic

Joseph G. Jurcic, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-30

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-01-30

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Myeloid Neoplasm
Cancer

Additional Relevant MeSH Terms

Acute Myeloid Leukemia