A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study aims to find the recommended doses of lisaftoclax and olverembatinib to give with decitabine. It is for adults with advanced chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute myeloid leukemia (Ph+ AML), a blood cancer with a certain gene change.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with CML in the accelerated phase or myeloid blast phase, or with Ph+ AML.
- Have tried at least one BCR::ABL1 TKI, a targeted cancer drug, that did not work or caused side effects you could not tolerate.
- Have an ECOG activity score of 3 or less, a measure of how well you can do daily tasks.
- Have liver, heart, kidney, and pancreas function that meets the study rules. Some liver test exceptions may be approved by the lead study doctor.
- Be able to understand the study and agree to sign a consent form.
- Be willing to use suitable birth control before joining, during the study, and for 6 months after finishing.
Who can't join
- Past treatment with lisaftoclax or olverembatinib, or an allergic reaction to drugs like the study drugs.
- Pancreatitis (swelling of the pancreas) within the past year, or long-term pancreatitis.
- Severe heart failure or serious, uncontrolled heart or blood vessel disease. This includes certain recent heart attacks, strokes, or blood clots; weak heart pumping; certain abnormal heart rhythms; or uncontrolled high blood pressure.
- A serious infection not controlled by treatment, or leukemia in the brain or spinal cord. HIV is allowed only if well controlled on steady treatment. Hepatitis B or C may exclude you, though some people with no detectable virus may qualify.
- Another past or current cancer requires discussion with the lead study doctor and must not interfere with judging the study treatment's safety or effect.
- Recent use of certain drugs or supplements that affect how the body handles medicines, such as rifampin or St. John's wort. Chemotherapy or experimental leukemia drugs within 7 days may also exclude you; some treatments and situations are allowed.
- Being unable to swallow, being pregnant, or breastfeeding.
- A mental health condition or life situation that would make it hard to follow the study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 criteria: 1. 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 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x ULN, unless due to the underlying leukemia approved by the PI 3. Creatinine clearance ≥30 mL/min 4. 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 study participation, and for 6 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence,, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Exclusion Criteria: 1. Participants who have previously received lisaftoclax or olverembatinib 2. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis 3. Active grade III-V cardiac failure as defined by the New York Heart Association Criteria 4. 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. ii. Left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment. iii. Diagnosed or suspected congenital long QT syndrome. iv. Clinically significant atrial or ventricular arrhythmias (such as uncontrolled, clinically significant atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician. v. Prolonged QTc interval on pre-entry electrocardiogram (\> 480 msec) unless corrected after electrolyte replacement. vi. History of venous thromboembolism including deep venous thrombosis or pulmonary embolism within the past 3 months, excluding line associated DVT of the upper extremity vii. Uncontrolled hypertension (diastolic blood pressure \>100mmHg; and systolic \>150mmHg). 5. Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment). 6. Active central nervous system leukemia 7. Known human immunodeficiency virus (HIV) seropositive, unless well-controlled on stable doses of anti-retroviral therapy. 8. 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 surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Participants who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load. 9. Participants with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI 10. 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 11. 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 to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea, cytarabine (up to 2 g/m2 given for cytoreduction within the preceding 7 days) and/or an FDA-approved BCR::ABL1 TKI is permitted. 12. Inability to swallow 13. Pregnant or breastfeeding women will not be eligible 14. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Decitabine, Lisaftoclax, and Olverembatinib or other agents used in study. 15. Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Study sites (1)
TX
- MD Anderson Cancer Center · Houston, TX 77030Nicholas Short, MD · Study contact · 713-563-4485 · nshort@mdanderson.orgNicholas Short, MD · Principal investigatorMore trials in Houston