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New treatment option for Chronic Myeloid Leukemia, Chronic Phase
Official title Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
ClinicalTrials.gov ID: NCT05143840
What this study is testing
What is Single Agent Asciminib?
Single Agent Asciminib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic myeloid leukemia, chronic phase.
Also referred to as ABL001.
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 study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP.
- Phase 2: a mid-size study of how well it works
- 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
- Age ≥18 years old
- Willing and able to give informed consent
- Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy/aspirate and have either the b3a2 (e14a2)...
- Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific...
- ECOG performance status 0-2 (appendix 1)
You likely can't join if
- Patients with accelerated or blast phase CML (refer to appendix 4)
- Active second malignancy requiring active treatment
- History of recent (within 12 months) acute pancreatitis or chronic pancreatitis
- people who have previously received treatment with asciminib.
- people with PLT count \< 50,000 mm3 or ANC of \< 500 mm3 or Hemoglobin \< 8 g/dL
- Cardiac or cardiac repolarization abnormality, including any of the following:
See the full eligibility criteria
- Age ≥18 years old
- Willing and able to give informed consent
- Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy/aspirate and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein...
- Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed with no time restrictions within the eligible...
- ECOG performance status 0-2 (appendix 1)
- Adequate organ function:
- AST and ALT \< 3 times the institutional upper limit of normal (ULN)
- eGFR ≥ 30 mL/min as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https://www.kidney.org/professionals/kdoqi/gfr\_calculator)
- Total bilirubin \< 1.5 times the institutional ULN or \< 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)
- Adequately controlled blood pressure, defined as systolic blood pressure of \<140 mmHq and diastolic of \<90 mmHg, at the time of enrollment.
- Lipase ≤ 1.5 x ULN. For lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.
- Creatine phosphokinase \< 2.5 x ULN
- Female patients must meet one of the following:
- Postmenopausal for at least one year before the screening visit,
- Surgically sterile
- If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug,
- Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not...
- Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose
- Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not...
- Patients with accelerated or blast phase CML (refer to appendix 4)
- Active second malignancy requiring active treatment
- History of recent (within 12 months) acute pancreatitis or chronic pancreatitis
- people who have previously received treatment with asciminib.
- people with PLT count \< 50,000 mm3 or ANC of \< 500 mm3 or Hemoglobin \< 8 g/dL
- Cardiac or cardiac repolarization abnormality, including any of the following:
- History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
- QTcF at screening greater than or equal to 450 msec (male patients), greater than or equal to 460 msec (female patients) unless patient has a pacemaker
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia...
- Pregnant or lactating
- Taking a strong inhibitors or inducers of CYP3A4 or CYP3A4 substrates with narrow therapeutic index (refer to appendix 6) at time of enrollment
- Unable to comply with lab appointment schedule and PRO assessments
- Another investigational drug within 4 weeks of enrollment
- Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol
- Patient has undergone a prior allogeneic stem cell transplant
- Known clinical history of active HBV infection
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, 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 Birmingham, Alabama, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States; Detroit, Michigan, United States; Buffalo, New York, United States; New York, New York, United States and 2 more location(s). 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.