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

Phase 1

• Conditions: Chronic lymphocytic leukemia; Non-Hodgkin's lymphoma; Multiple Myeloma; T prolymphocytic leukemia; Chronic myeloid leukemia; Waldenstrom's macroglobulinemia lymphoma and Relapsed/refractory pediatric malignancies; Acute Myelogenous Leukemia (AML); MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2018-004356-38-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To obtain long-term safety data for subjects from ongoing venetoclax studies;Secondary Objective: Not applicable;Primary end point(s): There are no clinical hypotheses being tested;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.