RecruitingPhase 1

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

United States30 participantsStarted 2024-08-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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:
✕. 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 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.

What they're measuring

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT06401603

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Nicholas Short, MD

(713) 563-4485 nshort@mdanderson.org

View on ClinicalTrials.gov More Advanced Chronic Myeloid Leukemia trials