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New treatment option for Leukemia, Myeloid, Chronic
Official title Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
ClinicalTrials.gov ID: NCT04260022
What this study is testing
What is Ascentage Pharma HQP1351 bioavailable inhibitor?
Ascentage Pharma HQP1351 bioavailable inhibitor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leukemia, myeloid, chronic.
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
- A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation
- For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib...
- For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib...
- The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for...
- Three months after the initiation of therapy: non-complete hematologic response (CHR) and/or Ph+ \>95%
You likely can't join if
- Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia...
- Received other therapies as follows:
- For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or...
- For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351
- For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the...
- Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351
See the full eligibility criteria
Who can join
- For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation
- For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care
- For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a...
- The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line...
- Three months after the initiation of therapy: non-complete hematologic response (CHR) and/or Ph+ \>95%
- Six months after the initiation of therapy: BCR-ABL1\>10% and/or Ph+ \>35%
- Twelve months after the initiation of therapy: BCR-ABL1\>1% and/or Ph+ \>0%
- Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a...
- The definition of resistance to second-line TKI treatment a) For CML CP patients: the patients must meet at least one criterion as follows: i.) Three months after the initiation of therapy: No CHR or Ph+ \>95% or new...
- Intolerance to TKIs is defined as:
- Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP...
- Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR...
- Patients providing written informed consent before initiation of any study-related activities
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Minimum life expectancy of 3 months or more
- Patients with adequate organ function as defined below:
- Creatinine \ 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL/min (Cockcroft-Gault)
- Serum albumin ≥ 3.0 g/dL
- Total bilirubin \< 1.5 × ULN
- Aspartate aminotransferase (AST [Serum glutamic oxaloacetic transaminase (SGOT)]) and alanine aminotransferase (ALT [serum glutamate-pyruvate transaminase (SGPT)]) \< 3 × ULN for institution (\<5×ULN if liver...
- Serum amylase and lipase ≤ 1.5 × ULN
- Prothrombin time (PT) ≤ 1.5 × ULN
- Heart function: Left ventricular ejection fraction (LVEF) \> 50%
- Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms
- For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of...
- Ability to comply with study procedures, in the Investigator's opinion
What rules you out
- Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any...
- Received other therapies as follows:
- For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other...
- For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351
- For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351
- Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351
- Patients who had been treated with HQP1351
- Patients requiring immunosuppressive therapy other than short time of steroid
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
- Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \>140/90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP...
- Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
- Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months
- Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months
- Any history of peripheral vascular infarction, including visceral infarction within 6 months
- 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 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition...
- Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.
- Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression...
- CML CP patients with CCyR
- Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL
- Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment
- Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)
- Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered...
- Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV...
- Patients with COVID-19 who now present with positive swab
- Patients who have poorly controlled diabetes, defined as HbA1C values of \> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.
- Known allergy to any components in the study drug
- Pregnant or lactating
- Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and how well it works to...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Baltimore, Maryland, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Toronto, Ontario, Canada
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 Birmingham, Alabama, United States; Duarte, California, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States; Baltimore, Maryland, United States; Cleveland, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.