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A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
EU CTIS ID: 2024-517131-52-00
What this study is testing
The primary objective of this study is to compare the efficacy of sonrotoclax plus obinutuzumab versus venetoclax plus rituximab in patients with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Therapeutic confirmatory (Phase III)
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
- Patients aged ≥ 18 years with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria (Hallek et al 2018).
- Patients must have ≥ 1 prior therapy for CLL/SLL. For each line of therapy, patients must receive at least 2 cycles of this therapy.
- For patients who received a BCL2i, only those with CLL/SLL who received BCL2i in the first line setting with fixed duration therapy, have a remission for ≥ 3 years, and have a time interval of ≥ 2 years from the last dose of BCL2i to screening, are eligible. Patients should be informed about their options to choose other approved CLL/SLL therapies in this setting.
- Indications for CLL/SLL therapy are met by one of the criteria per the iwCLL 2018 criteria, with minor modification as discussed in the main protocol.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2.
- Adequate marrow function as defined by: – Absolute neutrophil count ≥ 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case the absolute neutrophil count must be ≥ 0.75 x 109 cells/L (without growth factor support within the past 7 days). – Platelet counts ≥ 75 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), the platelet count should be ≥ 30 x 109 cells/L (without growth factor support or transfusion within the past 7 days). – Hemoglobin > 75 g/L (may be posttransfusion).
You likely can't join if
- No active infection including hepatitis B or C virus or HIV at the time of study treatment initiation.
- No active prolymphocytic leukemia or currently suspected Richter’s transformation at the time of consideration for study.
- No ongoing clinically significant cardiovascular or pulmonary disease that prevents participation.
- No central nervous system involvement by CLL/SLL.
- No history of prior or active malignancy within 18 months, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy: – Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. – Adequately treated cervical carcinoma in situ without evidence of disease. – Localized prostate cancer with Gleason score ≤ 6 or controlled prostate cancer with androgen deprivation treatment. – Treated early-stage breast cancer with or without hormonal therapy.
- No other active antineoplastic treatment.
See the full eligibility criteria
Who can join
- Patients aged ≥ 18 years with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria (Hallek et al 2018).
- Patients must have ≥ 1 prior therapy for CLL/SLL. For each line of therapy, patients must receive at least 2 cycles of this therapy.
- For patients who received a BCL2i, only those with CLL/SLL who received BCL2i in the first line setting with fixed duration therapy, have a remission for ≥ 3 years, and have a time interval of ≥ 2 years from the last dose of BCL2i to screening, are eligible. Patients should be informed about their options to choose other approved CLL/SLL therapies in this setting.
- Indications for CLL/SLL therapy are met by one of the criteria per the iwCLL 2018 criteria, with minor modification as discussed in the main protocol.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2.
- Adequate marrow function as defined by: – Absolute neutrophil count ≥ 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case the absolute neutrophil count must be ≥ 0.75 x 109 cells/L (without growth factor support within the past 7 days). – Platelet counts ≥ 75 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), the platelet count should be ≥ 30 x 109 cells/L (without growth factor support or transfusion within the past 7 days). – Hemoglobin > 75 g/L (may be posttransfusion).
- Adequate liver function as indicated by aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limits of normal (ULNs) value; serum total bilirubin ≤ 1.5 x ULNs (unless documented Gilbert syndrome where total bilirubin ≤ 3 x ULNs).
- Adequate renal function, defined by a value ≥ 30 mL/min, determined either by creatinine clearance directly measured with a 24-hour urine collection or via estimated glomerular filtration rate calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation.
- Life expectancy > 6 months.
What rules you out
- No active infection including hepatitis B or C virus or HIV at the time of study treatment initiation.
- No active prolymphocytic leukemia or currently suspected Richter’s transformation at the time of consideration for study.
- No ongoing clinically significant cardiovascular or pulmonary disease that prevents participation.
- No central nervous system involvement by CLL/SLL.
- No history of prior or active malignancy within 18 months, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy: – Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. – Adequately treated cervical carcinoma in situ without evidence of disease. – Localized prostate cancer with Gleason score ≤ 6 or controlled prostate cancer with androgen deprivation treatment. – Treated early-stage breast cancer with or without hormonal therapy.
- No other active antineoplastic treatment.
- No CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Korea, Republic of
- New Zealand
- China
- United Kingdom
- Brazil
- Canada
- Argentina
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 Australia; United States; Korea, Republic of; New Zealand; China; United Kingdom and 3 more location(s). 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.