Decitabine and Cedazuridine for Leukemia, Myeloid, Acute

Phase-Based Estimates
1
Effectiveness
1
Safety
Vanderbilt University/Ingram Cancer Center, Nashville, TN
Leukemia, Myeloid, Acute+3 More
Decitabine and Cedazuridine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Myeloid, Acute

Study Summary

This study is evaluating whether a combination of medications can help treat people with acute myeloid leukemia.

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Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Decitabine and Cedazuridine will improve 4 primary outcomes and 7 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of End of each cycle (1 cycle = 28 days).

Day 28
Recommended phase 2 dose (RP2D) of decitabine and cedazuridine (ASTX727) in combination with venetoclax (Phase Ib)
Recommended safe phase 2 dose (RP2D) of decitabine and cedazuridine (ASTX727) in combination with venetoclax (Phase Ib)
Year 5
Overall survival (OS) (Phase II)
Month 3
Event-free survival (EFS) (Phase II)
Up to 5 years
Complete response rate (Phase II)
Duration of response (Phase II)
Incidence of adverse events (Phase Ib)
Mutational burdens in venetoclax + ASTX727 sensitive vs. resistant AML leukemia initiating cells (LICs) (Phase II)
Overall response rate (Phase II)
Progression-free survival (PFS) (Phase II)
The proportion of treatment naive AML patients receiving stem cell transplantation (SCT) following treatment with venetoclax and ASTX727 (Phase II)

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Arm II (cytarabine, daunorubicin)
Phase Ib (decitabine and cedazuridine, venetoclax)

This trial requires 18 total participants across 3 different treatment groups

This trial involves 3 different treatments. Decitabine And Cedazuridine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Phase Ib (decitabine and cedazuridine, venetoclax)Patients receive ASTX727 PO QD on days 1-4 or 1-5 of each cycle and venetoclax PO QD on days 1-28 or days 1-21 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Arm I (decitabine and cedazuridine, venetoclax)Patients receive ASTX727 PO QD at the recommended phase II dose and venetoclax PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Arm II (cytarabine, daunorubicin)Patients receive cytarabine IV over 24 hours on days 1-7 of each cycle and daunorubicin IV over 10-30 minutes on days 1-3 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Vanderbilt University/Ingram Cancer Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Myeloid, Acute or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must be between 18-65 years of age at the time of signing the Informed Consent Form (ICF) and must be able to meet all study requirements. show original
You have a morphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria. show original
Adverse risk AML per 2017 European LeukemiaNet (ELN) recommendations
Subjects must be either treatment naive defined by =< 1 cycle of deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) therapy, no history of cytotoxic chemotherapy for their AML; prior treatment with lenalidomide, hydroxyurea or erythropoiesis-stimulating agents (ESAs) is allowed (prior treatment for myelodysplastic syndrome [MDS] with > 1 cycle of DNMTi is not allowed)
A bone marrow aspirate and biopsy must be performed, and tissue collected for entrance to the trial
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Recovery to =< grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia
White blood cell count (WBC) < 25,000 (may be reduced with leukopheresis or hydroxyurea prior to study start)
Bilirubin is in the institutional ULN. show original
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of leukemia, myeloid, acute?

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Leukemic symptoms include fever, enlarging lymph nodes, chest pains, and loss of consciousness. Myelodysplastic syndrome can also manifest itself in children through symptoms such as anemia or leukopenia. Other signs include unexplained bleeding and bruising, and headaches, especially after strenuous exercise.\n

Unverified Answer

What is leukemia, myeloid, acute?

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Leukemia, myeloid, acute, is a disorder of the blood and the bone marrow that can cause an abnormal development in cells. It is the most common type of blood cancers and one of the three most common cancers worldwide.\n

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How many people get leukemia, myeloid, acute a year in the United States?

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Although the number of people diagnosed with acute leukemia is rising, fewer people in the United States are being diagnosed with acute leukemia, partly because of an increase in the latency of diagnostic interval among adults.

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What are common treatments for leukemia, myeloid, acute?

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Most common treatments are supportive in nature, such as corticosteroids, supportive care protocols (e.g., transfusions, platelet transfusions, antibiotic regimens, and inotropic agents) and supportive care protocols for chemotherapy, bone marrow transplants and stem cell donors (e.g., erythropoietin). Some treatments including (or have been combined with) radiation therapy are commonly used in combination with chemotherapy for acute myeloid and lymphoid leukemia. However, even in this context, some treatment options are still considered rare or exceptional, such as leukoablative therapy or bone marrow transplantation.

Unverified Answer

What causes leukemia, myeloid, acute?

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The most common causes of adult AML, according to a study by Dana-Farber Cancer Institute are: non-Hodgkin's Lymphoma (30%), chronic myeloid leukemia (CML, 3%), and AML involving other blood cancers, which was the most common type of leukemia in the study. When leukemia is the cause of a child's health problems, then the most common cause will be acute myeloid leukemia. In children, the most common cause of this disease will be acute lymphoblastic leukemia, which is the blood cancer responsible for the body's defenses against infections and cancer.

Unverified Answer

Can leukemia, myeloid, acute be cured?

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While not a common question on oncology.com, it is often heard in conversations among patients and their families. The answer depends highly on the type of leukemia involved. There are some very aggressive types, including acute myeloid leukemia and MDS, such as APLL, that are usually fatal. However, when treated aggressively, such as with allogeneic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation or intensive chemotherapy, the remission rate could approach 90%. In most cases, however, less aggressive methods, such as induction of a second complete complete remission, are used. Here, the cure rate can reach less than 30%.

Unverified Answer

What are the chances of developing leukemia, myeloid, acute?

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Acute leukemia may develop in patients having one or more acute leukemias and/or in patients with chronic leukemias. Myeloid leukemia will most often develop in patients having 1 or 2 myelogenous leukemias, and acute leukemic syndromes are most likely to occur in patients having 2 or more.

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Does leukemia, myeloid, acute run in families?

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Leukemia, myeloid, acute run in families does not occur. The occurrence of leukemias of different kinds within the same family of the same degree of relationship suggests that this disorder presents itself with a genetic predisposition and is not an autosomal dominant (i.e. inherited), X-linked disorder.

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Have there been other clinical trials involving decitabine and cedazuridine?

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There has not been a trial comparing decitabine or cedazuridine mononucleoside with or without high-dose cytarabine in people with AML. However, if AML is not detected by cytogenetics or bone marrow biopsy, and disease relapses occur, another drug may be indicated. Although decitabine is highly active in preclinical models of AML and ALL, the evidence for clinical use is presently insufficient.

Unverified Answer

How serious can leukemia, myeloid, acute be?

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Symptoms of the leukemia and myeloid, acute may often only become apparent when you are very sick and are unable to get your regular treatment, which happens to people with leukemia and/or myeloid, acute a fairly often. Symptoms in these conditions might be as vague and far less severe than symptoms of people with leukemia or myeloid, chronic or leukemia.

Unverified Answer

What are the common side effects of decitabine and cedazuridine?

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The most common and serious side effect is myelosuppression. Decitabine (Dec or Decz) and cedazuridine (Ceda or Cedaza) have almost identical toxicity. The incidence of myelosuppression was 16.5% in patients randomized to Dec versus 18% in patients randomized to Ced. The rate of serious myelosuppression was 4% in patients randomized to Dec versus 1% in patients randomized to Ced. Other common side effects included nausea, rash, diarrhea, and constipation. Severe allergic reactions occurred very rarely (3%).

Unverified Answer

Is decitabine and cedazuridine typically used in combination with any other treatments?

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With only a rare exception, the results of clinical trials showed that decitabine and cedazuridine are usually combined with some immunomodulatory, cytotoxic or tyrosine kinase inhibitor treatments.

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