Is NCT04260022 recruiting in Baltimore, MD?

Yes, NCT04260022 is currently recruiting participants at its Baltimore, MD location. This leukemia, myeloid, chronic clinical trial is actively enrolling qualified participants.

How do I join the leukemia, myeloid, chronic clinical trial in Baltimore?

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

Is participation in this Baltimore 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.

Leukemia, Myeloid, Chronic Clinical Trial in Baltimore, MD

About This Leukemia, Myeloid, Chronic Study in Baltimore

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.

Sponsor: Ascentage Pharma Group Inc.

Who Can Participate

Inclusion Criteria

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 T315I mutation, number of pretreated TKIs is not restricted.

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 treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:

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 BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)

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 mutations ii.) Six months after the initiation of therapy: BCR-ABL1\>10% and/or Ph+ \>65% and/or new mutations iii.) Twelve months after the initiation of therapy: BCR-ABL1\>1% and/or Ph+ \>35% and/or new mutations iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA/Ph+) b) For CML AP patients: the patients must meet at least one criterion as follows: i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR) ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR c) For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows: i) One month after the initiation of therapy: failure to achieve a MaHR ii) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week iii) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR

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 patients or MaHR for AP/BP or Ph+ ALL patients

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 for AP/BP or Ph+ ALL patients

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 × upper limit of normal (ULN); or, 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 involvement with leukemia)

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 contraception with their sexual partners throughout participation in this study

Ability to comply with study procedures, in the Investigator's opinion

Exclusion Criteria

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 other treatments

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 radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351

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 can be considered to be included. ("well controlled HBP" is defined as: HBP can be ≤ 140/90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.

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 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 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.

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 in recent 6 months prior to informed consent date

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 disease-free at the time of study entry.

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 antibody must have an undetectable HCV viral load.

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 efficacy to the study drug

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 Baltimore?

Yes, this clinical trial (NCT04260022) has an active research site in Baltimore, MD 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.

Leukemia, Myeloid, Chronic Treatment Options in Baltimore, MD

If you're searching for leukemia, myeloid, chronic treatment options in Baltimore, MD, this clinical trial (NCT04260022) 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 Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced leukemia, myeloid, chronic 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 leukemia, myeloid, chronic clinical trials near you to find additional studies recruiting in your area.

Leukemia, Myeloid, Chronic Clinical Trial in Baltimore, MD

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