Decitabine and Cedazuridine for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Leukemia, Myelogenous, Chronic, BCR-ABL Positive+8 More
Decitabine and Cedazuridine - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of ASTX727 and dasatinib is more effective than either drug alone.

See full description

Eligible Conditions

  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • BCR-ABL1 Positive Chronic Myelogenous Leukemia
  • Philadelphia Chromosome Positive
  • Chronic Phase Phase Chronic Myelogenous Leukemia (CML)
  • BCR-ABL1 Positive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Objectives

This trial is evaluating whether Decitabine and Cedazuridine will improve 1 primary outcome and 5 secondary outcomes in patients with Leukemia, Myelogenous, Chronic, BCR-ABL Positive. Measurement will happen over the course of At 12 months.

At 12 months
Major molecular response rate
Rate of MR4.5
At 6 months
Rate of molecular response 4 (MR4)
Up to 15 years
Overall survival
Time to progression
Treatment-free remission rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Trial Design

1 Treatment Group

Treatment (dasatinib, decitabine and cedazuridine)
1 of 1
Experimental Treatment

This trial requires 70 total participants across 1 different treatment group

This trial involves a single treatment. Decitabine And Cedazuridine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (dasatinib, decitabine and cedazuridine)Patients receive dasatinib PO QD on days 1-28. Beginning cycle 4, patients also receive decitabine and cedazuridine PO QD on days 1-3. Cycles repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days for up to 12 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received newly diagnosed for Leukemia, Myelogenous, Chronic, BCR-ABL Positive or one of the other 8 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Your total bilirubin level should be less than 1.5 times the upper limit of normal, unless it is secondary to Gilbert's disease, in which case it should be less than 2.5 times the upper limit of normal. show original
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
or nilotinib) For patients with Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML, the diagnosis is in early chronic phase if it is within 12 months of being diagnosed show original
The serum glutamic pyruvic transaminase level is lower than three times the upper limit of normal. show original
Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study
Eastern Cooperative Oncology Group (ECOG) performance of 0-2
Creatinine < 1.5 x ULN

Patient Q&A Section

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

"Over the past 10 years, the development of CDDP for the treatment of AML and MDS has been largely uneventful except for the introduction of CDDP as monotherapy. However, recent studies have demonstrated that CDDP is active against CMML and provided a rationale for the exploration of CDDP in this indication. Results from recent clinical trials have confirmed the effectiveness of CDDP in patients with CMML. This agent appears to be well tolerated with no significant side effects. Further data are awaited before clinical recommendations regarding the use of CDDP in CMML can be made." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia, myeloid, chronic-phase?

"No new treatments and treatments are available for AML, CML, and CMLCP, which are currently treated with standard chemotherapy regimens. However, it should be noted that there have been many advances in research on the development of novel therapies. New drug developments include [bortezomib] (Velcade), [everolimus] (Afinitor), [Rituxan] (Rituxan), [atasiban] (Copanlisib), [ibritumomab tiuxetan] (Zevalin), [pomalidomide] (Entycal), and alemtuzumab (Campath)." - Anonymous Online Contributor

Unverified Answer

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

"Findings from a recent study suggest that while Dec plus Ceda does not appear to be an effective therapy in the treatment of smoldering AML, it may be useful in preventing relapses and prolonging survival, particularly in patients with B-CLL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, myeloid, chronic-phase?

"There are still many questions to be answered about the pathogenesis of CML and how we might better treat it. Some aspects of this disease are becoming clearer, such as its potential to develop into acute myelogenous leukemia with minimal change disease. Some other new findings from recent studies include new insights into epigenetic mechanisms, gene expression and splicing, and the role of microRNAs in progression of CML. Improvements in our understanding of the biology of CML will hopefully lead to improved treatments. For example, identification of the mechanisms underpinning resistance to tyrosine kinase inhibitors (TKIs), which are being used therapeutically to treat patients with CML, has led to the development of second generation TKIs." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, myeloid, chronic-phase?

"Symptoms of leukemia, myeloid, chronic-phase include fever, chills, night sweats, weight loss, feeling tired, and headache. A complete blood count (CBC), bone marrow biopsy, and chest x-ray should be performed in all cases of unexplained fever, night sweats, and weight loss. A bone marrow examination, peripheral blood smear, and bone marrow aspiration should be performed in cases of unexplained fatigue, headache, and malaise; however, if no abnormality is found on a CBC, a peripheral blood smear, and a bone marrow examination, a chest x-ray should be performed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, myeloid, chronic-phase?

"For many people with hematological malignancies, chemotherapy seems to provide remission and prolong survival. In a recent study, we found that there is no difference between local therapy and systemic therapy. Future studies should focus on the role of early intervention before the development of leukemia-associated complications and use of different approaches to enhance the quality of life of long-term survivors." - Anonymous Online Contributor

Unverified Answer

How serious can leukemia, myeloid, chronic-phase be?

"A significant proportion of patients die from acute leukemic crisis (ALC). Because ALC is potentially life-threatening, even mild symptoms warrant urgent treatment. As ALC progresses, patients become increasingly frail and may benefit from palliative care." - Anonymous Online Contributor

Unverified Answer

How quickly does leukemia, myeloid, chronic-phase spread?

"A diagnosis of acute myelogenous leukemia has been shown to change prognosis only if the disease has not yet invaded the bone marrow; this is complicated because solid tumors such as cancers of the liver, lung, brain, and breast are capable of infiltrating the bone marrow without interfering with its function. Therefore, in many patients, blood counts continue to rise even after chemotherapy has begun, indicating that leukemia cells are still alive and reproducing despite therapy. It is possible that the initial spread of cancer into the bone marrow occurs rapidly (within days), but the bulk of disease growth takes place more slowly." - Anonymous Online Contributor

Unverified Answer

Is decitabine and cedazuridine safe for people?

"Decitabine is well tolerated and appears to be an active agent for the treatment of MDS. The combination of decitabine and cyclophosphamide showed promising activity in our study. There was no evidence of biosafety issues when using decitabine in combination with cyclophosphamide. Decitabine plus azacitidine should be considered in future clinical trials." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia, myeloid, chronic-phase?

"As mentioned above, clinical trials for leukemia, myeloid, chronic phase may be considered for individuals who have been previously treated, given the high toxicity associated with conventional chemotherapy. In addition, clinical trials could be considered for individuals who do not fit the criteria for aforementioned clinical trials. For example, in the case of acute myeloid leukemia (AML), age < 60 years, performance status 0-2, and one remission prior to enrollment in a clinical trial. Clinical trials for AML may be considered for elderly patients (> 60 years old) experiencing an < 50% remission rate after two cycles of induction chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia, myeloid, chronic-phase?

"The primary cause of [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia) was associated with an increased frequency of chromosome translocations and other genetic abnormalities. The majority of relapsed acute myeloid leukemias were preceded by transient myeloproliferative disorders. The primary cause of chronic myelogenous leukemia was the acquisition of a Philadelphia chromosome. The primary cause of chronic lymphocytic leukemia was the B-cell lineage." - 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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