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MEDI-538 (Blinatumomab) in CLL
NCT00676871Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jun 2008
- Primary completion
- Mar 2010
- Sponsor
- MedImmune
- Modality
- Antibody Conjugates, scFv Fragments, Bispecific Antibodies
- Drugs
- blinatumomab
- Conditions
- chronic lymphocytic leukemia (CLL)
01
Overview
Phase 2, open-label, single-arm trial of blinatumomab in chronic lymphocytic leukemia (CLL), sponsored by MedImmune. Primary endpoints: Safety and Tolerability of MEDI-538, Maximum Tolerated Dose and 1 more. Planned start Jun 2008; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
MEDI-538
Continuous IV infusion of MEDI-538 at escalated doses (Phase 1) or MTD (Phase 2).
03
Who it enrols
Adult patients with B-cell CLL who have residual disease (measurable or MRD positive) following previous therapy, ECOG <= 2, and adequate organ function. Requires a live-in companion and central venous catheter.
04
Endpoints
Primary
Safety and Tolerability of MEDI-538
Maximum Tolerated Dose
Overall Response
Secondary
Pharmacokinetics
Immunogenicity
Antitumor Activity
Time to MRD Relapse
Time to Progression
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