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Trial Info
Trial Info
Status: Open
Specialty: Haematology
Date Opened: 09/06/2021
Planned Close Date: 31/05/2025
Sponsor: Abbvie
Principal Investigator: Dr Macheta
Trial Description
Trial Description
Blood cancers like Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin’s lymphoma (NHL), and Acute Lymphoblastic Leukemia (ALL) are grouped under the umbrella of hematologic (blood) malignancies (cancers). The purpose of this extension study is to provide Venetoclax to and see how safe it is for participants who continue to tolerate and obtain benefit from receiving the drug in ongoing studies.
Venetoclax is an oral drug developed for the treatment of various blood cancers. It kills cancer cells by blocking a protein (part of a cell) that allows cancer to stay alive. Participants in this study will continue to receive Venetoclax at the same dose administered to them during the previous study in which they were enrolled. If patients are receiving other drugs at the time of study entry, they may continue to receive them, but the other drugs will not be supplied or reimbursed. Adult participants with diagnosis of CLL, AML, MM, NHL, and ALL participating in ongoing Venetoclax studies will be enrolled. Around 550 participants will be enrolled in the study in approximately 323 sites worldwide.
Participants will receive oral Venetoclax daily and will be evaluated per standard of care. Participants should return every 12 weeks (± 2 weeks) to continue receiving Venetoclax and will be monitored for adverse events (side effects) and use of concomitant (associated) medicines. Participants will receive Venetoclax daily until discontinued from the study.
There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects and completing questionnaires.
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.
- Patients are willing or able to comply with procedures required in this protocol.
- Subjects should not receive any live vaccines during study participation including until at least 4 weeks after the last dose of study drug.
- Patients entering the extension study with multiple myeloma must adhere to the following guidelines:
• All patients 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 (500mg to 1g, twice daily) or levofloxacin (500mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines.
- Patients 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.
• Patients agree to abide by protocol-mandated pregnancy avoidance measures.
- All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must be vaccinated against pneumococcus (live attenuated vaccines are not allowed).
- All other subjects (not only those receiving treatment with venetoclax in combination with a proteasome inhibitor) may also receive anti‐infective prophylaxis with antibiotics at the Investigator's discretion or per institutional guidelines.
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 study or for approximately 90 days after the last dose of study drug.
Contacts
Contacts
Link to EDGE
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