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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ 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:

⁃ 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 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.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Nicholas Short, MD
nshort@mdanderson.org
(713) 563-4485
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 30
Treatments
Experimental: Phase 1
Participants enrolled in Phase I, the dose of lisaftoclax you receive will depend on when a participants join this study. Up to 2 dose levels of lisaftoclax will be tested. Between 3-12 participants will be enrolled at each dose level.
Experimental: Phase 2
Participants enrolled in Phase II, participants will receive lisaftoclax at the recommended dose that was found in Phase I
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Ascentage Pharma Group Inc.

This content was sourced from clinicaltrials.gov