Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020, China
NCT Number: NCT05594784
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.
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Notify Me14 year and older
All sexes
Interventional
Phase 2
Tianjin, 300020, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a third-generation TKI
a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Glucocorticoids
Anti-tumor alkaloids
Time frame: At 3 months of treatment (90 days)
Complete molecular remission rate (CMR rate) at 3 months of treatment (90 days)
Time frame: up to 60 months
From the date of registration to the date of death resulting from any cause
Time frame: up to 60 months
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day
Time frame: an expected average of 24 months
Time frame: an expected average of 3 months
Time frame: up to 60 months
Time frame: up to 60 months
Institute of Hematology & Blood Diseases Hospital, China
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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