CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Olverembatinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05594784
NCT05594784Phase 2Completed

Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Oct 26, 2022·Updated Jun 3, 2025

In Brief

A Phase 2 clinical trial evaluating Olverembatinib, Venetoclax, and 2 other interventions for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 26, 2022
Enrollment StartOct 8, 2022
Primary CompletionMar 25, 2025
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 3.7 years ago

Interventions

Olverembatinibdrug

a third-generation TKI

Venetoclaxdrug

a selective inhibitor of B-cell lymphoma 2 (Bcl-2)

prednisonedrug

Glucocorticoids

Vincristinedrug

Anti-tumor alkaloids