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New treatment option for Advanced Chronic Myeloid Leukemia
Official title A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06401603
What this study is testing
What is Decitabine?
Decitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced chronic myeloid leukemia.
Also referred to as Dacogen.
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
- To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.
- Phase 1: an early, usually small safety study
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
- a) Diagnosis: Age ≥18 years with CML-AP, CML-MBP, or Ph+ AML by WHO 2016 criteria.
- Participants must have been intolerant or resistant to at least one prior BCR::ABL1 TKI 2\. Performance status ≤3 (ECOG Scale). 3\. Adequate liver...
- Total serum bilirubin \< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x ULN, unless due to the underlying leukemia approved by the PI
- Creatinine clearance ≥30 mL/min
You likely can't join if
- Participants who have previously received lisaftoclax or olverembatinib
- History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- Clinically significant and uncontrolled cardiovascular disease, including but not restricted to: i. Myocardial infarction (MI), stroke...
- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial...
- Active central nervous system leukemia
See the full eligibility criteria
- a) Diagnosis: Age ≥18 years with CML-AP, CML-MBP, or Ph+ AML by WHO 2016 criteria.
- Participants must have been intolerant or resistant to at least one prior BCR::ABL1 TKI 2\. Performance status ≤3 (ECOG Scale). 3\. Adequate liver, cardiac, renal and pancreatic function as defined by the following...
- Total serum bilirubin \< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x ULN, unless due to the underlying leukemia approved by the PI
- Creatinine clearance ≥30 mL/min
- Serum amylase or lipase \< 1.5 x ULN 4\. Ability to understand and the willingness to sign a written informed consent document 5\. Willingness to use adequate contraception prior to study entry, for the duration of...
- Participants who have previously received lisaftoclax or olverembatinib
- History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- Clinically significant and uncontrolled cardiovascular disease, including but not restricted to: i. Myocardial infarction (MI), stroke, revascularization, unstable angina, or transient ischemic attack within 6 months...
- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
- Active central nervous system leukemia
- Known human immunodeficiency virus (HIV) seropositive, unless well-controlled on stable doses of anti-retroviral therapy.
- Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection Note: Participants who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B...
- Participants with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or how well it works assessment of the investigational regimen may be included only...
- Consumed strong inducer of CYP3A or p-glycoprotein within 14 days of study enrollment, or 5 half-lives, whichever is longer. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged...
- Inability to swallow
- Pregnant or breastfeeding women will not be eligible
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Decitabine, Lisaftoclax, and Olverembatinib or other agents used in study.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.