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Tyrosine Kinase Inhibitor

Dasatinib + Venetoclax for Chronic Myelogenous Leukemia

Phase 2

Waitlist Available

Led By Elias Jabbour, MD

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

Diagnosis of Ph-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤ 12 months). Except for hydroxyurea and/or 1 to 2 doses of cytarabine patients must have received no or minimal prior therapy, defined as <1 month (30 days) of prior FDA approved TKI.

Must not have

Diagnosed or suspected congenital long QT syndrome

Patients in late chronic phase, accelerated or blast phase are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a combination of two drugs can effectively treat early stage chronic myelogenous leukemia.

Who is the study for?

This trial is for adults with early chronic phase chronic myelogenous leukemia that's Philadelphia chromosome positive or BCR-ABL1 positive. They should have minimal prior treatment, good kidney function, and acceptable blood test results. Pregnant women, those with serious heart disease, bleeding disorders, uncontrolled infections or psychiatric conditions are excluded.

What is being tested?

The study tests dasatinib and venetoclax's effectiveness in treating certain leukemia by blocking enzymes needed for cancer cell growth. It’s a phase II trial to see how well these drugs work together in patients who've had little to no previous treatment.

What are the potential side effects?

Potential side effects may include nausea, fatigue, risk of infection due to low white blood cell counts, liver issues indicated by changes in blood tests results, diarrhea or constipation from digestive system reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and move around.

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I have early-stage CML with minimal prior treatment.

Exclusion Criteria

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

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I have or might have long QT syndrome.

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My cancer is not in the late, accelerated, or blast phase.

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I do not have uncontrolled mental health issues like psychosis, major depression, or bipolar disorder.

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I do not have any uncontrolled infections or need treatment for hepatitis B or C.

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My heart condition severely limits my daily activities.

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I have never had serious irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Major molecular response (MMR) defined as BCR-ABL transcripts (IS) =< 0.1%

Secondary study objectives

Complete cytogenetic response (CCR) defined as 0% Ph-positive metaphases, or fluorescence in situ hybridization =< 2%, or BCR-ABL transcripts (IS) =< 1%

Incidence of toxicities, defined as grade 3 or higher pleural effusion

Overall survival

+1 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Hypotension

Hypertension

Intracranial hemorrhage

Enterocolitis

Small intestinal obstruction

Lower gastrointestinal hemorrhage

Fungemia

Peripheral motor neuropathy

Typhlitis

Oropharyngeal pain

Multi-organ failure

Abdominal pain

Hypoxia

Kidney infection

Edema limbs

Sinus bradycardia

Gastric hemorrhage

Myocardial infarction

Diarrhea

Fibrinogen decreased

Aspiration

Atrial fibrillation

Delirium

Endophthalmitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

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, venetoclax)Experimental Treatment3 Interventions

Patients receive dasatinib PO QD for 15 years in the absence of disease progression or unacceptable toxicity. After 3 months of dasatinib treatment, patients also receive venetoclax PO QD on days 1-14 of each month for 3 years in the absence of disease progression or unacceptable toxicity (patients enrolled prior to 4/1/2018 receive only dasatinib).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasatinib

2012

Completed Phase 3

~2320

Venetoclax

2019

Completed Phase 3

~2240