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A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination with Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
EU CTIS ID: 2024-512147-23-00
What this study is testing
To evaluate the incidence of treatment-emergent laboratory TLS per Howard criteria or treatment-emergent hyperkalemia (potassium > 6.0 mmol/L), both requiring clinical intervention that has been confirmed by an Independent Review Committee (IRC) assessment in previously untreated subjects with CLL achieving either a medium tumor burden with CrCl of at least 80 mL/min or low tumor burden (regardless of CrCl level) after debulking therapy, during the venetoclax ramp-up period (5-, 6- or 7-week).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.
- Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
- Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula
You likely can't join if
- Active/uncontrolled infection or Richter's transformation or active immune thrombocytopenia.
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- Australia
- Puerto Rico
- Taiwan
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; Australia; Puerto Rico; Taiwan; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.