Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia

Conditions

• Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olverembatinib plus venetoclax and dexamethasone — DRUG
  Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28

Study Details

The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.

Key Dates

Start date

Nov 1, 2023

Status verified

Nov 2022

Primary completion

Nov 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: OVD regimen of Olverembatinib plus venetoclax and dexamethasone
  Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28

Primary Outcome Measure

Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates [ Time Frame: Three years ]