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New treatment option for Chronic Phase Chronic Myelogenous Leukemia
Official title Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
ClinicalTrials.gov ID: NCT04838041
What this study is testing
What is Asciminib 40 MG?
Asciminib 40 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic phase chronic myelogenous leukemia.
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 is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI).
- 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
- Eligibility for Consolidation Treatment Phase
- Age ≥18 years old.
- Willing and able to give informed consent.
- Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 \^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2)...
- Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib...
You likely can't join if
- History of accelerated or blast phase CML.
- A 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 platelet (PLT) count \< 100 × 109/L or an absolute neutrophil count (ANC) of \< 1 × 109/L or hemoglobin \< 8 g/dL.
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≥3 times the institutional upper limit of normal.
See the full eligibility criteria
- Eligibility for Consolidation Treatment Phase
- Age ≥18 years old.
- Willing and able to give informed consent.
- Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 \^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification...
- Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib, imatinib or nilotinib.
- Must have met all the following criteria prior to first attempt to discontinue their TKI:
- Stable molecular response (MR4; \ 2 years (with allowance for a two-week variance), as documented on at least four tests, performed at least three months apart (e.g., If a patient has had \>4 PCR tests performed during...
- Treatment with one of the following FDA approved TKIs; imatinib, dasatinib, nilotinib at any dose for a minimum of approximately three years (allowance of a four-week variance) prior to discontinuing TKIs.
- Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed).
- Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR::ABL1 \>0.1% IS after first attempted TKI discontinuation.
- After first failed TFR attempt, must have a minimum duration of one year of retreatment with TKI, and must plan to remain on that TKI or switch to asciminib for a minimum of 12 months during the consolidation treatment...
- Current TKI must be the same as the TKI being taken prior to the initial TFR attempt (e.g., if patient is on imatinib prior to first TFR attempt, they should be on imatinib at time of enrollment on this study).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
- Must have a RQ-PCR for BCR::ABL1 \< 0.0032% IS (MR4.5) reported by the trial designated central lab at the time of study enrollment.
- Lipase ≤ 1.5 x upper limit of normal (ULN). For lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.
- 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)
- 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...
- History of accelerated or blast phase CML.
- A 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 platelet (PLT) count \< 100 × 109/L or an absolute neutrophil count (ANC) of \< 1 × 109/L or hemoglobin \< 8 g/dL.
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≥3 times the institutional upper limit of normal.
- Total bilirubin ≥ 1.5 times the institutional upper limit of normal (unless direct bilirubin is within normal limits).
- Pregnant or lactating.
- Unable to comply with lab appointment schedule and patient-reported outcome (PRO) assessments.
- Another investigational drug within four 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.
- Screening 12-lead electrocardiogram (ECG) showing a baseline corrected QT interval \>480msec (patients with a pacemaker will still be eligible with QTc\>500msec).
- Known active hepatitis B infection. Eligibility for TFR Phase:
- Stable molecular response (MR4.5; \< 0.0032% IS) documented on at least three tests (may include TFR phase screening PCR) by the trial designated lab, performed approximately three months apart while on consolidation...
- TFR phase screening PCR RQ-PCR for BCR::ABL1 \< 0.0032% IS (MR4.5) by the trial designated lab.
- ECOG 0-3.
- Completion of 12 cycles on the consolidation therapy phase.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, 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 Detroit, Michigan, United States; New York, New York, United States; Salt Lake City, Utah, United States; Milwaukee, Wisconsin, 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.