CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Blinatumomabdrug
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/NCT05557110
NCT05557110Phase 2Completed

A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia

Chen Suning·interventional·Posted Sep 27, 2022·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Blinatumomab for B Acute Lymphoblastic Leukemia. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects. In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedSep 27, 2022
Enrollment StartSep 8, 2022
Primary CompletionJan 5, 2024
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.8 years ago

Interventions

Blinatumomabdrug

Reduced-intensity chemotherapy followed by Blinatumomab