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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)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517959-12-00
Acronym
GMALL-BLIVEN
Enrollment
21
Registered
2024-11-05
Start date
2024-04-11
Completion date
Unknown
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory B cell precursor acute lymphoblastic leukemia

Brief summary

Phase I: Maximum tolerated dose (MTD) Phase II: mol-CR rate in patients with CR/CRh/CRi as assessed by molecular MRD analyses of bone marrow cells obtained after one treatment cycle

Interventions

DRUGVenclyxto 10 mg film-coated tablets
DRUGVenclyxto 100 mg film-coated tablets
DRUGVenclyxto 50 mg film-coated tablets

Sponsors

Goethe University Frankfurt
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase I: Maximum tolerated dose (MTD) Phase II: mol-CR rate in patients with CR/CRh/CRi as assessed by molecular MRD analyses of bone marrow cells obtained after one treatment cycle

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026