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

First listed

May 6, 2024

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)

Find similar trials in Houston, TX