Clinical Trial: NCT05182385
Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Goethe University |
| Information Provided By: | Goethe University |
| Last Update Posted: | 2025-07-25 |
Study Overview
Brief Summary
This study is designed to determine the feasibility, safety, tolerability and maximum tolerated dose of Venetoclax in combination with Blinatumomab and to evaluate the response in patients treated with the combination of Venetoclax and Blinatumomab in in patients with hematological relapse or molecular relapse.
Official Title
An Open Label, Phase I/II Study of Venetoclax in Addition to Blinatumomab Immunotherapy in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)
Conditions
ALL, Recurrent, Adult
Intervention / Treatment
- Drug: Blinatumomab
- Drug: Venetoclax
Other Study ID Numbers
- GMALL-BLIVEN
- 2021-001384-25
Start Date (Actual)
2021-12-15
Primary Completion Date (Estimated)
2026-04-30
Study Completion Date (Estimated)
2026-04-30
Enrollment (Actual)
30
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Goethe University |
| Information Provided By: | Goethe University |
| Last Update Posted: | 2025-07-25 |
Study Overview
Brief Summary
This study is designed to determine the feasibility, safety, tolerability and maximum tolerated dose of Venetoclax in combination with Blinatumomab and to evaluate the response in patients treated with the combination of Venetoclax and Blinatumomab in in patients with hematological relapse or molecular relapse.
Official Title
An Open Label, Phase I/II Study of Venetoclax in Addition to Blinatumomab Immunotherapy in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)
Conditions
ALL, Recurrent, Adult
Intervention / Treatment
- Drug: Blinatumomab
- Drug: Venetoclax
Other Study ID Numbers
- GMALL-BLIVEN
- 2021-001384-25
Start Date (Actual)
2021-12-15
Primary Completion Date (Estimated)
2026-04-30
Study Completion Date (Estimated)
2026-04-30
Enrollment (Actual)
30
Study Type
Interventional
Phase
Phase 1, Phase 2