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.
Eligible Conditions
- Chronic Myelogenous Leukemia (CML)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Up to 5 years
At 6 months
MCyR at 6 months (MCyR6)
Up to 24 months
Duration of MCyR
MMR
Day 30
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
Up to 5 years
Time to transformation to accelerated phase CML
Time to transformation to blastic phase CML
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Treatment (Ponatinib Hydrochloride)
75%Fatigue
58%Rash maculo-papular
58%Constipation
58%Abdominal pain
50%Nausea
42%Edema limbs
42%Platelet count decreased
33%Alkaline phosphatase increased
25%Hypertension
25%Diarrhea
17%Vomiting
17%Alanine aminotransferase increased
17%Anorexia
17%Cough
8%Fever
8%Pneumonitis
8%Dry skin
8%Back pain
8%Arthralgia
8%Pancreatitis
8%Pleural effusion
8%Lymphocyte count decreased
8%Hoarseness
8%Headache
8%Blood bilirubin increased
8%CD4 lymphocytes decreased
8%Neutrophil count decreased
8%Hyperglycemia
8%Anemia
8%Sepsis
8%White blood cell decreased
Trial Design
1 Treatment Group
Ponatinib hydrochloride
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Ponatinib Hydrochloride · No Placebo Group · Phase 2
Ponatinib hydrochlorideExperimental Group · 3 Interventions: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Ponatinib Hydrochloride · Intervention Types: Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ponatinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,808 Previous Clinical Trials
1,790,441 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,093 Previous Clinical Trials
41,143,270 Total Patients Enrolled
Elias Jabbour, MDPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
929 Total Patients Enrolled
Jorge CortesPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
348 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have Philadelphia chromosome (Ph)-positive (by cytogenetics or FISH) or breakpoint cluster region (BCR)-ABL-positive (by PCR) chronic myeloid leukemia.
You have a performance of 0-2 on the ECOG scale.
You have a serum glutamate pyruvate transaminase (SGPT) level of < 2.
Creatinine is less than 1.5 times the upper limit of normal.
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Conditions
Cancer Related
Treatments