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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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Duration of MCyR
MMR
Time to transformation to accelerated phase CML
+1 moreSide effects data
From 2019 Phase 2 trial • 12 Patients • NCT0226534175%
Fatigue
58%
Abdominal pain
58%
Rash maculo-papular
58%
Constipation
50%
Nausea
42%
Edema limbs
42%
Platelet count decreased
33%
Alkaline phosphatase increased
25%
Hypertension
25%
Diarrhea
17%
Cough
17%
Vomiting
17%
Alanine aminotransferase increased
17%
Anorexia
8%
Arthralgia
8%
CD4 lymphocytes decreased
8%
White blood cell decreased
8%
Pleural effusion
8%
Pancreatitis
8%
Sepsis
8%
Headache
8%
Anemia
8%
Blood bilirubin increased
8%
Fever
8%
Hyperglycemia
8%
Back pain
8%
Dry skin
8%
Lymphocyte count decreased
8%
Hoarseness
8%
Pneumonitis
8%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ponatinib Hydrochloride)
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: 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
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,596 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,988 Total Patients Enrolled
Jorge CortesPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself and perform daily activities.My high blood pressure is not under control.My chronic myeloid leukemia is in an advanced stage.I have had pancreatitis in the last year.My CML is in the accelerated phase.My condition has worsened but not reached an advanced stage.I have taken more than one approved or experimental drug for my leukemia.My leukemia is in the early stage and tests positive for specific genetic markers.My organs are functioning well.I am using effective birth control methods.I have been treated with a BCR-ABL inhibitor other than bosutinib, dasatinib, or nilotinib.I have severe heart disease that limits my daily activities.I have had a heart attack, unstable chest pain, stroke, or mini-stroke.I have had severe heart failure in the last 6 months.I am using effective birth control methods.My cancer did not respond to a specific approved cancer drug.I stopped taking bosutinib, dasatinib, or nilotinib at least 2 days ago.I do not have any serious or uncontrolled heart conditions.My diabetes is not well-managed.I have a history of serious heart rhythm problems.I have had a blood clot in a vein within the last 6 months.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Ponatinib hydrochloride
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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