RecruitingPhase 1Phase 2NCT06082934

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

An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia


Sponsor

Xijing Hospital

Enrollment

30 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — olverembatinib, venetoclax, and dexamethasone — in patients newly diagnosed with a specific form of leukemia called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This combination targets multiple pathways to try to achieve remission without requiring intensive chemotherapy. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Ph+ acute lymphoblastic leukemia (a type of fast-growing blood cancer) - Your liver, kidneys, and heart are functioning adequately - Your expected survival is more than 3 months - You are willing to use contraception and meet pregnancy testing requirements **You may NOT be eligible if...** - You are currently enrolled in another clinical trial - You are pregnant or breastfeeding - You have had major surgery within the past 3 weeks - You have an active infection requiring IV medications - You have HIV or active hepatitis infection - You have severe lung disease (COPD with very low breathing function) - You have difficulty swallowing or absorbing oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlverembatinib 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


Locations(1)

Department of Hematology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shannxi, China

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NCT06082934