Ponatinib Hydrochloride for Chronic Myelogenous Leukemia (CML)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Myelogenous Leukemia (CML)+2 MorePonatinib Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02265341) in the Treatment (Ponatinib Hydrochloride) ARM group. Side effects include: Fatigue with 75%, Rash maculo-papular with 58%, Constipation with 58%, Abdominal pain with 58%, Nausea with 50%.

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.