Decitabine and Cedazuridine for Acute Myeloid Leukemia (AML)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Acute Myeloid Leukemia (AML)+3 More
Decitabine and Cedazuridine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called decitabine can be used to treat acute myeloid leukemia.

See full description

Eligible Conditions

  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acute Myeloid Leukemia (AML)

Study Objectives

This trial is evaluating whether Decitabine and Cedazuridine will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Acute Myeloid Leukemia (AML). Measurement will happen over the course of From complete remission or complete remission with incomplete count recovery until date of first objective documentation of relapse or death, assessed up to 5 years.

Year 5
Relapse-free survival (RFS)
Year 5
Overall survival (OS)
Year 5
Event-free survival (EFS)
Up to 5 years
Duration of remission
Incidence of adverse events
Minimal residual disease
RFS (Intensive induction cohort)
RFS (Lower intensity induction cohort)

Trial Safety

Safety Progress

1 of 3

Other trials for Acute Myeloid Leukemia (AML)

Trial Design

5 Treatment Groups

Arm D (decitabine and cedazuridine, enasidenib)
1 of 5
Arm E (decitabine and cedazuridine, ivosidenib)
1 of 5
Arm C (decitabine and cedazuridine, gilteritinib)
1 of 5
Arm A (decitabine and cedazuridine)
1 of 5
Arm B (decitabine and cedazuridine, venetoclax)
1 of 5
Experimental Treatment

This trial requires 125 total participants across 5 different treatment groups

This trial involves 5 different treatments. Decitabine And Cedazuridine is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Arm D (decitabine and cedazuridine, enasidenib)Patients receive decitabine and cedazuridine PO QD on days 1-3 and enasidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Arm E (decitabine and cedazuridine, ivosidenib)Patients receive decitabine and cedazuridine PO QD on days 1-3 and ivosidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Arm C (decitabine and cedazuridine, gilteritinib)Patients receive decitabine and cedazuridine PO QD on days 1-3 and gilteritinib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Arm A (decitabine and cedazuridine)
Drug
Patients receive decitabine and cedazuridine PO QD on days 1-3. Treatments repeat every 28 days for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (decitabine and cedazuridine, venetoclax)Patients receive decitabine and cedazuridine PO QD on days 1-3 and venetoclax PO QD on days 1-5. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
FDA approved
Enasidenib
FDA approved
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

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Acute Myeloid Leukemia (AML) 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:
Patients aged >= 18 years AML who have achieved their FIRST complete response (CR) or complete response with incomplete bone marrow recovery (CRi) and are not immediately candidates for allogeneic stem cell transplant
Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) should have received remission induction therapy and at least 1 consolidation cycle. These patients are eligible as long as they are not greater than 2 months from their last consolidation therapy and will be designated as COHORT 1 (intensive induction cohort)
Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine [LDAC] or hypomethylating agent [HMA]-based therapy) to achieve remission should have received at least 2 cycles of lower intensity therapy between the time they have achieved CR/CRi and enrollment on this protocol. They will be designated as COHORT 2 (lower intensity induction cohort)
For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any time without maximum 'time from consolidation' requirement
Eastern Cooperative Oncology Group (ECOG) performance status of < or = 3
Serum total bilirubin < or = to 1.5 x the upper limit of normal (ULN)
Serum creatinine < or = to 2.5 x ULN
Absolute neutrophil count (ANC) > 0.5 x k/uL
Platelet count > or = 50 x k/uL
Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling

Patient Q&A Section

What is the latest research for leukemia, myeloid, acute?

"This section will summarize recent advances in the understanding of leukemogenesis and its therapy. It has long been suspected that the uncontrolled proliferation of white blood cells is the pathologic basis of leukemia. Today, it is well known that leukemia develops from hematopoietic stem cells (HSC), which give rise to all blood cell types through differentiation. However, the mechanism of progression from HSC to LSC was not fully understood until recently." - Anonymous Online Contributor

Unverified Answer

What is decitabine and cedazuridine?

"Decitabine and cedazuridine can be administered safely as a single agent during all phases of chemotherapy for high-risk MDS. Both agents have been shown to increase overall response rates when used in combination with other chemotherapy regimens, but only decitabine has been associated with improved progression-free survival." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in decitabine and cedazuridine for therapeutic use?

"Decitabine was superior to the previously used agent, dideoxycytidine, for achieving remission of AML. Higher rates of remission were observed in patients treated with decitabine (55%) versus those treated with dideoxycytidine (40%).decitabine is now approved for usage in the United States. However, there is no evidence that it improves survival. Cedazuridine has not been approved for use in the United States. In Europe, however, it is approved for use in combination with fludarabine and cyclophosphamide for treating newly diagnosed refractory AML. ClinicalTrials.gov Identifier: NCT01616861." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia, myeloid, acute?

"Clinical trials represent an important option for patients with newly diagnosed AML. However, there is no clear evidence that participation in a clinical trial alters survival outcomes." - Anonymous Online Contributor

Unverified Answer

Can leukemia, myeloid, acute be cured?

"Yes, it is possible to cure a person with acute leukemia, myeloid, or lymphoma by treatment with chemotherapy. This cure is most likely if all the necessary steps are taken before the disease gets bad enough to start treatment. The more advanced the disease is at diagnosis, the less likely it is that a cure will happen. Doctors use multiple treatments to fight leukemia, though the exact treatment plan depends upon the type of leukemia and the stage of the disease. After treatment, all three types of leukemia can be cured. If the leukemia has not spread beyond the bone marrow and stays there, then the chances of being cured are stronger. The chance of being cured increases as the number of treatments a person has received decreases over time." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of decitabine and cedazuridine?

"Decitabine and cedazuridine are both effective, safe, and well tolerated for the treatment of patients with advanced malignancies. Although there was no difference between the two drugs in terms of the major adverse events included In a recent study, we observed a higher incidence of nausea and neutropenia among patients given decitabine than those given cedazuridine." - Anonymous Online Contributor

Unverified Answer

Has decitabine and cedazuridine proven to be more effective than a placebo?

"In addition to the results from our initial study, we found the addition of decitabine plus cedazuridine to standard intensive chemotherapy provides no benefit compared with standard-intensity chemotherapy with both agents. Considering the number of patients needed to detect a meaningful difference in survival, our study suggests that this strategy is not cost-effective." - Anonymous Online Contributor

Unverified Answer

Does leukemia, myeloid, acute run in families?

"Results from a recent clinical trial supports the hypothesis that AML runs in families and that other types of ALL do not seem to run in families." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia, myeloid, acute?

"Myeloid, acute leukemia is caused by uncontrolled cell growth in the bone marrow. There are many genetic mutations that contribute to leukemia. However, there is one specific gene mutation (TET2) that makes up about 30% of all cases of leukemia. TET2 is an enzyme that helps to maintain normal blood cell numbers and functions correctly. When TET2 doesn't work properly, the body's defenses against cancer go wrong. This is why it is important to understand what works in different patients so doctors can prescribe the best treatment. [Anderson et al.](https://www.ncbi.nlm.nih.gov/books/NBK06726/check_lists/hemlock_trivellona." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, myeloid, acute?

"The majority of acute leukemia cases were caused by a genetic defect in one or more of the components of the DNA repair pathway. This is consistent with the notion that cancer is due to a gradual accumulation of mutations in DNA repair genes. However, there was limited evidence for other mechanisms, such as environmental factors influencing the expression of DNA repair genes or epigenetic changes leading to decreased DNA repair." - Anonymous Online Contributor

Unverified Answer

What is leukemia, myeloid, acute?

"Acute leukemias and myeloproliferative disorders comprise a heterogeneous group of diseases. This article focuses on acute myeloid leukemia (AML). AML is one of the most common cancers diagnosed in young adults, making up approximately 20% of all cases in adults age 18-35 years. The incidence rate of AML has increased over the past two decades. As of 2008, it was estimated that 15-20% of newly diagnosed patients had AML as their initial diagnosis, while 25% of patients with AML will die within 5 years from diagnosis. Much of the information presented here is generalizable to other forms of AML." - Anonymous Online Contributor

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