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Tyrosine Kinase Inhibitor

Dasatinib + Venetoclax for Chronic Myelogenous Leukemia

Q: What primary purpose is Dasatinib typically prescribed for?

<a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a> is an effective therapy for those suffering from <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a>, small lymphocytic <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, and chronic lymhocytic leukemia.

Q: How many participants are currently involved in this research endeavor?

Affirmative. According to the information on clinicaltrials.gov, this medical study is actively looking for participants as of June 24th 2022; it was initially posted almost 6 years prior in February 2016. Currently, 140 patients are sought after from a single location.

Q: What other research studies have been conducted utilizing Dasatinib?

At present, there are 279 active trials researching <a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a> with 37 of these being at the Phase 3 stage. Edmonton, Alberta is currently hosting most of these studies however 11452 locations globally have also opened clinical trials for this drug.

Q: Is this clinical trial still recruiting participants?

This trial, which was initially posted on February 19th 2016 and recently updated June 24th 2022, is actively searching for participants. Evidenced by clinicaltrials.gov.

Q: What has the Food and Drug Administration determined about Dasatinib?

There is preliminary evidence that supports the safety of <a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a>, hence it has been assigned a score of 2. As this is still in Phase 2 trials, no data exists to confirm its efficacy yet.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am able to care for myself and move around.

Select...

I have early-stage CML with minimal prior treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Atrial fibrillation

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

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

~1990

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,647 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,512 Total Patients Enrolled

Elias Jabbour, MDPrincipal InvestigatorM.D. Anderson Cancer Center

13 Previous Clinical Trials

1,075 Total Patients Enrolled

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02689440 — Phase 2

Frequently Asked Questions

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

What primary purpose is Dasatinib typically prescribed for?

"Dasatinib is an effective therapy for those suffering from acute lymphoblastic leukemia, small lymphocytic lymphoma, and chronic lymhocytic leukemia."

Answered by AI

How many participants are currently involved in this research endeavor?

"Affirmative. According to the information on clinicaltrials.gov, this medical study is actively looking for participants as of June 24th 2022; it was initially posted almost 6 years prior in February 2016. Currently, 140 patients are sought after from a single location."

Answered by AI

What other research studies have been conducted utilizing Dasatinib?

"At present, there are 279 active trials researching Dasatinib with 37 of these being at the Phase 3 stage. Edmonton, Alberta is currently hosting most of these studies however 11452 locations globally have also opened clinical trials for this drug."

Answered by AI

Is this clinical trial still recruiting participants?

"This trial, which was initially posted on February 19th 2016 and recently updated June 24th 2022, is actively searching for participants. Evidenced by clinicaltrials.gov."

Answered by AI

What has the Food and Drug Administration determined about Dasatinib?

"There is preliminary evidence that supports the safety of Dasatinib, hence it has been assigned a score of 2. As this is still in Phase 2 trials, no data exists to confirm its efficacy yet."

Answered by AI

Recent research and studies

CancerJournal

Early Results of Lower Dose Dasatinib (50 Mg Daily) as Frontline Therapy for Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia

Naqvi, Kiran, Elias Jabbour, Jeffrey Skinner, Musa Yilmaz, Alessandra Ferrajoli, Prithviraj Bose, Philip Thompson, et al.. 2018. “Early Results of Lower Dose Dasatinib (50 Mg Daily) as Frontline Therapy for Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia”. Cancer. Wiley. doi:10.1002/cncr.31357.

CancerJournal

Long‐term Follow‐up of Lower Dose Dasatinib (50 Mg Daily) as Frontline Therapy in Newly Diagnosed Chronic‐phase Chronic Myeloid Leukemia

Naqvi, Kiran, Elias Jabbour, Jeffrey Skinner, Kristin Anderson, Sara Dellasala, Musa Yilmaz, Alessandra Ferrajoli, et al.. 2019. “Long‐term Follow‐up of Lower Dose Dasatinib (50 Mg Daily) as Frontline Therapy in Newly Diagnosed Chronic‐phase Chronic Myeloid Leukemia”. Cancer. Wiley. doi:10.1002/cncr.32504.

clinicaltrials.govStudy

Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia

2016. "Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02689440.

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