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Nucleoside Analog

ASTX727 + Dasatinib for Chronic Myeloid Leukemia

Phase 2

Recruiting

Led By Elias Jabbour

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance of 0-2

Must not have

Active, uncontrolled psychiatric disorders

Presence of any features of accelerated phase CML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase.

Who is the study for?

This trial is for adults newly diagnosed with Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in the early chronic phase. They should have minimal prior treatment, good organ function, and an ECOG performance of 0-2. Pregnant women, those with serious heart disease, significant bleeding disorders, uncontrolled infections or hepatitis B/C are excluded.

What is being tested?

The trial is testing ASTX727 (a chemotherapy drug) combined with dasatinib (an enzyme blocker) to treat chronic myeloid leukemia. It aims to see if this combination can control cancer cell growth by killing cells or stopping them from dividing and spreading.

What are the potential side effects?

Potential side effects may include nausea, fatigue, muscle pain, changes in blood counts leading to increased infection risk or bleeding problems. Heart rhythm issues could occur due to dasatinib. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled mental health issues.

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My chronic myeloid leukemia is in an accelerated phase.

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I have severe heart disease.

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I have or might have long QT syndrome.

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I am a woman who could get pregnant and am not using effective birth control.

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My CML is in the late chronic, accelerated, or blast phase.

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I am HIV positive.

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I am being treated for chronic hepatitis B or C.

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I have a history of a serious bleeding disorder not related to my cancer.

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I have had serious heart rhythm problems.

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I currently have an untreated or uncontrollable infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of molecular response 4 (MR4)

Secondary study objectives

Major molecular response rate

Overall survival

Rate of MR4.5

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dasatinib, decitabine and cedazuridine)Experimental Treatment2 Interventions

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

2012

Completed Phase 3

~2320

0 / 12Eligibility criteria met