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

Conditions

• Advanced Chronic Myeloid Leukemia
• Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Decitabine — DRUG
  Given by IV
• Listaftoclax — DRUG
  Given by PO
• Olverembatinib — DRUG
  Given by PO

Study Details

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.

Key Dates

Start date

Aug 6, 2024

Status verified

Apr 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Nicholas Short, MD
  (713) 563-4485
  [email protected]

Locations (1)

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