An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004356-38-FR

Enrollment

550

Registered

2019-08-08

Start date

2021-08-03

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Chronic lymphocytic leukemia

Interventions

Product Name: Venetoclax Product Code: ABT-199 (GDC-0199) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Venetoclax CAS Number: 1257044-40-8 Current Sponsor code: ABT-199 (GDC-0199) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject has completed a prior venetoclax study, and the investigator believes that continued treatment with venetoclax is in the best interest of the patient. - Subjects are willing or able to comply with procedures required in this protocol. - Subjects entering the extension study with multiple myeloma must adhere to the following guidelines: • All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must receive prophylaxis with antibiotics while on treatment and for at least 30 days after discontinuation of the proteasome inhibitor and/or venetoclax including: Bactrim forte® (1 tablet, 3 times a week) or equivalent antibiotic therapy AND Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines - Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. • Subjects agree to abide by protocol-mandated pregnancy avoidance measures. Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 294 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: • Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. • Male who is considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To obtain long-term safety data for subjects from ongoing venetoclax studies;Secondary Objective: Not applicable;Primary end point(s): Adverse event collection;Timepoint(s) of evaluation of this end point: Subjects may continue on study until the subject experiences an adverse event which jeopardizes subject safety, disease progression, death, voluntary withdrawal, or until venetoclax is approved and reimbursable for the treated indication in the country of participation.	—

Measure

Time frame

Main Objective: To obtain long-term safety data for subjects from ongoing venetoclax studies;Secondary Objective: Not applicable;Primary end point(s): Adverse event collection;Timepoint(s) of evaluation of this end point: Subjects may continue on study until the subject experiences an adverse event which jeopardizes subject safety, disease progression, death, voluntary withdrawal, or until venetoclax is approved and reimbursable for the treated indication in the country of participation.

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Countries

Australia, Austria, Belgium, Denmark, France, Greece, Poland, Portugal, Sweden, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+441628 561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026