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New treatment option for Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Official title 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 ID: NCT01746836
What this study is testing
What is Ponatinib Hydrochloride?
Ponatinib Hydrochloride is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic phase chronic myelogenous leukemia, bcr-abl1 positive.
Also referred to as AP24534 HCl, Iclusig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate, dasatinib, or nilotinib. Ponatinib hydrochloride may stop or control the growth of cancer cells by blocking a protein needed for cell growth.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization [FISH]) or breakpoint cluster region...
- Participants should have demonstrated to have failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and...
- Less than complete hematologic response (CHR) at or beyond 3 months
- No partial cytogenetic response at or beyond 3 months
- BCR-ABL1 ≥ 10% at or beyond 3 months
You likely can't join if
- Prior therapy with other BCR-ABL-targeted TKIs except bosutinib, dasatinib or nilotinib. Participants with T315I mutations are eligible and will be...
- Active NYHA cardiac class 3-4 heart disease
- Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
- Any history of MI, unstable angina, cerebrovascular accident, or TIA
- Any history of peripheral vascular infarction, including visceral infarction
- Any revascularization procedure, including the placement of a stent
See the full eligibility criteria
- Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization [FISH]) or breakpoint cluster region (BCR)-ABL-positive (by polymerase chain reaction [PCR]) CML in chronic phase.
- Participants should have demonstrated to have failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and nilotinib are approved as frontline therapy), defined as per European...
- Less than complete hematologic response (CHR) at or beyond 3 months
- No partial cytogenetic response at or beyond 3 months
- BCR-ABL1 ≥ 10% at or beyond 3 months
- BCR-ABL1 ≥ 1% at or beyond 6 months
- Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment
- Age \>18 years
- ECOG performance of 0-2.
- Adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless due to Gilbert syndrome, in which case it should be ≤3.0x ULN), SGPT ≤2.5x ULN, creatinine clearance (CrCL) ≥ 30 mL/min...
- Participants must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized:
- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential OR women who are surgically sterile.
- In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
- Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
- All WOCBP MUST have a negative pregnancy test prior to first receiving investigational product.
- Participants should have discontinued therapy with bosutinib, dasatinib or nilotinib or other anti-leukemia therapy (except hydroxyurea), at least 48 hours prior to start of study therapy and recovered from any toxicity...
- Prior therapy with other BCR-ABL-targeted TKIs except bosutinib, dasatinib or nilotinib. Participants with T315I mutations are eligible and will be analyzed separately.
- Active NYHA cardiac class 3-4 heart disease
- Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
- Any history of MI, unstable angina, cerebrovascular accident, or TIA
- Any history of peripheral vascular infarction, including visceral infarction
- Any revascularization procedure, including the placement of a stent
- Congestive heart failure (CHF) (New York Heart Association [NYHA] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local...
- History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
- Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment
- Participants with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
- Have uncontrolled hypertension (i.e., \>150 and \>90 for SBP and DBP, respectively). Participants with hypertension should be under treatment at study entry to ensure blood pressure control. Those requiring 3 or more...
- Have poorly controlled diabetes defined as HbA1c values of \> 7.5%. Participants with preexisting, well-controlled, diabetes are not excluded.
- Pregnant or breast-feeding women are excluded.
- Participants with history of pancreatitis within 1 year of study or history of chronic pancreatitis.
- Participants in accelerated or blast phase, or patients who have ever been documented to be in blast phase CML, are excluded. The definitions of excluded CML phases are as follows:
- Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow.
- Accelerated phase CML: presence of any of the following features:
- Peripheral or marrow blasts 15% or more
- Peripheral or marrow basophils 20% or more
- Thrombocytopenia \< 100 x 109/L unrelated to therapy
- Documented extramedullary blastic disease outside liver or spleen
- Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has been historically been included as a criterion for accelerated phase. However, participants with clonal...
- Participants who have received more than one FDA-approved TKI for CML, or any investigational, non-FDA approved TKI.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.