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-AT
• 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: 2020-12-28
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: A
• 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:
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.
• Subjects receiving any live vaccines during study participation including until at least 4 weeks (for all indications except MM) and 8 weeks (for subjects with MM) after the last dose of study drug.

Study & Design

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