TerminatedPhase 1

A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

Stopped: Business reasons, not related to safety or efficacy results.

United States84 participantsStarted 2018-05-31

Plain-language summary

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Acute promyelocytic leukemia
✕. Peripheral blast count \> 25 × 10 9/L
✕. Prior to the start of study treatment, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
✕. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

What they're measuring

Determine the safety and tolerability of voruciclib

Timeframe: 2 years

Determine the safety and tolerability of voruciclib in combination with venetoclax in subjects with AML.

Timeframe: 2 years

Trial details

NCT IDNCT03547115

SponsorMEI Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-24

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