A Phase 2 interventional study of Olverembatinib in Philadelphia-Positive ALL, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment
This is a multicenter, prospective, phase II study for adult de novo Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL) based on the combination of Olverembatinib and Blinatumomab. Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.
This is a prospective, multicenter, one-arm phase II clinical study, aimed for evaluating the effectiveness and safety of Olverembatinib combined with Blinatumomab in the treatment of newly diagnosed adult Ph + ALL patients.
Subjects enrolled in this study will be given a 14-day induction regimen of Olverembatinib 40mg qod orally combined with blinatumomab. To prevent cytokine release syndrome (CRS), the subjects are permitted to receive pretreatment with dexamethasone combined with Olverembatinib until the leukocyte count is less than 5 × 109/L. During induction therapy, Blinatumomab will be given in an incremental dose regimen, i.e., 9 μ g/day on days 1 to 3 and 28 μ g/day was used on days 4 to 14, and then stopped for 14 days.
Olverembatinib 40mg qod combined with blinatumomab will subsequently administered as a consolidation regimen. Blinatumomab was given a fixed dose regimen during consolidation treatment, i.e. 28 μ g/day from the day 1 to the day 28, and then stopped for 14 days. A total of 3-4 cycles will be administered, with every 42 days as one cycle.
At the end of the consolidation treatment, the patient received a maintenance regimen of Olverembatinib 40mg qod orally for at least 5 years. If the patient loses molecular response (defined as BCR-ABL1/ABL1 > 0.10%) during maintenance treatment, another consolidation treatment of 3-4 cycles of blinatumomab will be initiated.
During induction and consolidation treatment, lumbar puncture combined with sheath injection will be performed three times every cycle to prevent central nervous system leukemia (CSNL). If CNSL occurs at the time of admission, patients should receive regular conventional lumbar puncture and sheath injection for treating CNSL.
During the treatment, each subject will be evaluated regularly, including hematological response, minimal residual disease (through flow cytology, FCM-MRD), cytogenetic response and molecular remission rate, as well as adverse events.
The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients would be treated with Olverembatinib, Given PO, combined with Blinatumomab, Given intravenously
Drug: Olverembatinib
Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.
Also known as: Blinatumomab
Number of Participants with Complete Molecular Remission.
Will be estimated along with the 95% credible intervals.
Time frame: From Induction through the end of three cycles of blinatumomab (approximately 16 weeks)
Percentage of Participants with CR and Incomplete Complete Remission (CRi).
Will be estimated along with the 95% credible intervals.
Time frame: From Induction through the end of three cycles of blinatumomab (approximately 16 weeks)
Duration of Complete Molecular Remission.
Will be estimated along with the 95% credible intervals.
Time frame: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 to 7 years.
Event-free survival (EFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Time frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 7 years
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
Time frame: From the first day of treatment to time of death from any cause, assessed up 2 to 7 years.
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Time frame: Up to approximately 2 to 7 years
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University