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Tyrosine Kinase Inhibitor

Ponatinib for Chronic Myeloid Leukemia

Phase 2

Recruiting

Led By Jorge Cortes

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests ponatinib hydrochloride as second line therapy for CML patients who didn't respond to initial treatment with imatinib mesylate, dasatinib, or nilotinib, or can't tolerate those treatments. Ponatinib hydrochloride may work by blocking a protein needed for cell growth.

Who is the study for?

This trial is for patients with chronic myeloid leukemia in the chronic phase who didn't respond to or can't tolerate initial treatments like imatinib mesylate, dasatinib, or nilotinib. Participants must have normal organ function tests, be able to consent, and not be pregnant or breastfeeding. They should also have no severe heart disease, uncontrolled high blood pressure, psychiatric disorders, history of certain cardiovascular events, pancreatitis or more than one prior treatment with FDA-approved TKIs.Check my eligibility

What is being tested?

The trial is testing ponatinib hydrochloride as a second line therapy for chronic myeloid leukemia that's resistant or intolerant to first-line drugs. It includes laboratory biomarker analysis and quality-of-life assessments to see if this drug can control cancer cell growth by blocking proteins needed for their proliferation.See study design

What are the potential side effects?

Potential side effects of ponatinib hydrochloride may include risks such as pancreatitis (inflammation of the pancreas), changes in blood pressure and heart rhythm disturbances including prolonged QT interval which affects heart electrical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

MCyR at 6 months (MCyR6)

Time-to-toxicity defined as any grade 3 or 4 drug-related adverse event that is not responsive to standard therapeutic management and requires permanent treatment discontinuation

Secondary outcome measures

Duration of MCyR

MMR

Time to transformation to accelerated phase CML

+1 more

Side effects data

From 2019 Phase 2 trial • 12 Patients • NCT02265341

75%

Fatigue

58%

Abdominal pain

58%

Constipation

58%

Rash maculo-papular

50%

Nausea

42%

Edema limbs

42%

Platelet count decreased

33%

Alkaline phosphatase increased

25%

Diarrhea

25%

Hypertension

17%

Anorexia

17%

Cough

17%

Vomiting

17%

Alanine aminotransferase increased

Pleural effusion

Anemia

Arthralgia

Back pain

Headache

White blood cell decreased

Hyperglycemia

Hoarseness

Pneumonitis

Dry skin

Sepsis

Fever

Blood bilirubin increased

CD4 lymphocytes decreased

Lymphocyte count decreased

Neutrophil count decreased

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Ponatinib Hydrochloride)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ponatinib hydrochlorideExperimental Treatment3 Interventions

Patients receive ponatinib hydrochloride PO QD. Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ponatinib Hydrochloride

2014

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,271 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,956 Total Patients Enrolled

Jorge CortesPrincipal InvestigatorM.D. Anderson Cancer Center

8 Previous Clinical Trials

348 Total Patients Enrolled

Media Library

Ponatinib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01746836 — Phase 2

Chronic Myelogenous Leukemia Research Study Groups: Ponatinib hydrochloride

Chronic Myelogenous Leukemia Clinical Trial 2023: Ponatinib Hydrochloride Highlights & Side Effects. Trial Name: NCT01746836 — Phase 2

Ponatinib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01746836 — Phase 2

Frequently Asked Questions

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

Why did researchers design this clinical trial?

"The purpose of this study is to assess the rate of MCyR at 6 months post-treatment (MCyR6) and will secondary measure duration of MCyR, MMR, and time to transformation to accelerated phase CML."

Answered by AI

Are there any other precedents for this type of treatment?

"Ponatinib Hydrochloride is being trialed in 29 active studies, 3 of which are Phase 3 clinical trials. The highest concentration of these research centres for this medication are based in Roma and Gyeongsangbuk-do; however, there are 796 total locations running tests for Ponatinib Hydrochloride."

Answered by AI

What indications does Ponatinib Hydrochloride usually treat?

"Ponatinib Hydrochloride is an effective treatment against acute lymphoblastic leukemia (all), myeloid leukemia, chronic, chronic phase, and leukemia, myeloid, accelerated phase."

Answered by AI

How many people have been selected to participate in this clinical research?

"That is correct. Based on the information available on clinicaltrials.gov, it seems that this study is still open to recruiting patients. The trial was first posted on 1/17/2013 and edited for the last time on 6/15/2022. They are looking for 50 patients from a single site."

Answered by AI

Are we still enrolling individuals in this experiment?

"That is correct. The clinical trial is currently underway and recruiting 50 patients from a single site, as stated on the website clinicaltrials.gov. This information was originally posted on 1/17/2013 and was last updated on 6/15/2022."

Answered by AI

Has Ponatinib Hydrochloride been cleared for use by the FDA?

"Ponatinib Hydrochloride is considered to be a level 2 medication in terms of safety. While there is some evidence that it is safe, none of the clinical trials thus far have been able to confirm its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib

2013. "Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01746836.

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