Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial in Houston, TX

Q: Is NCT01746836 recruiting in Houston, TX?

Yes, NCT01746836 is currently recruiting participants at its Houston, TX location. This chronic phase chronic myelogenous leukemia, bcr-abl1 positive clinical trial is actively enrolling qualified participants.

Q: How do I join the chronic phase chronic myelogenous leukemia, bcr-abl1 positive clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Study in Houston

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.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion 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 leukemiaNet (ELN)35 or National Comprehensive Cancer Network (NCCN) recommendations:

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 (Cockcroft-Gault formula).

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 due to these therapies to at least grade 1. The use of hydroxyurea is allowed immediately prior to study entry.

Exclusion Criteria

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 institutional standards, within 6 months prior to enrollment

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 antihypertensive medications should be discussed with the PI.

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 evolution as the only criterion of accelerated phase have a significantly better prognosis. Thus, participants with clonal evolution and no other criteria for accelerated phase will be eligible for this study, but analyzed separately.

Participants who have received more than one FDA-approved TKI for CML, or any investigational, non-FDA approved TKI.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT01746836) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Treatment Options in Houston, TX

If you're searching for chronic phase chronic myelogenous leukemia, bcr-abl1 positive treatment options in Houston, TX, this clinical trial (NCT01746836) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic phase chronic myelogenous leukemia, bcr-abl1 positive specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic phase chronic myelogenous leukemia, bcr-abl1 positive clinical trials near you to find additional studies recruiting in your area.

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial in Houston, TX

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