BridgeMD
A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
EU CTIS ID: 2023-503469-49-00
What this study is testing
To assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC)
- 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
- Adult subjects who are: a. ≥65 years old or, b. 18 to 64 years old and have at least 1 of the following: - Cumulative Illness Rating Scale (CIRS) score >6 - Creatinine clearance (CrCl) estimated <70 mL/min using Cockcroft-Gault equation
- Diagnosis of CLL or SLL that meets iwCLL criteria
- Active CLL/SLL requiring treatment per the iwCLL criteria: a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia or thrombocytopenia or both; b. Massive (ie, at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly; c. Massive nodes (ie, at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy; d. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than six months; e. Constitutional symptoms, defined as 1 or more of the following: - Unintentional weight loss ≥10% within the previous 6 months prior to the start of screening; - Significant fatigue (inability to work or perform usual activities); - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without evidence of infection; - Night sweats for more than 1 month without evidence of infection
- Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node >1.5 cm in longest diameter
- ECOG Performance Status Grade ≤2
- Adequate organ function defined as follows: a. Absolute neutrophil count (ANC) ≥750 cells/μL independent of growth factor support; b. Platelets ≥50,000 cells/μL independent of transfusion support for at least 7 days prior to randomization; c. Hemoglobin >8.0 g/dL independent of transfusion support for at least 7 days prior to randomization; d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN); e. Total bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome); f. Estimated CrCl ≥30 mL/min (Cockcroft-Gault equation)
You likely can't join if
- Prior anti-leukemic therapy for CLL or SLL
- Received live, attenuated vaccine within 4 weeks of randomization
- History of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic condition that in the opinion of the investigator would adversely affect a subject's participation in the study
- Currently active, clinically significant Child-Pugh Class B or C hepatic impairment according to the Child Pugh classification
- Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Inability or difficulty swallowing capsules/tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
See the full eligibility criteria
Who can join
- Adult subjects who are: a. ≥65 years old or, b. 18 to 64 years old and have at least 1 of the following: - Cumulative Illness Rating Scale (CIRS) score >6 - Creatinine clearance (CrCl) estimated <70 mL/min using Cockcroft-Gault equation
- Diagnosis of CLL or SLL that meets iwCLL criteria
- Active CLL/SLL requiring treatment per the iwCLL criteria: a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia or thrombocytopenia or both; b. Massive (ie, at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly; c. Massive nodes (ie, at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy; d. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than six months; e. Constitutional symptoms, defined as 1 or more of the following: - Unintentional weight loss ≥10% within the previous 6 months prior to the start of screening; - Significant fatigue (inability to work or perform usual activities); - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without evidence of infection; - Night sweats for more than 1 month without evidence of infection
- Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node >1.5 cm in longest diameter
- ECOG Performance Status Grade ≤2
- Adequate organ function defined as follows: a. Absolute neutrophil count (ANC) ≥750 cells/μL independent of growth factor support; b. Platelets ≥50,000 cells/μL independent of transfusion support for at least 7 days prior to randomization; c. Hemoglobin >8.0 g/dL independent of transfusion support for at least 7 days prior to randomization; d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN); e. Total bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome); f. Estimated CrCl ≥30 mL/min (Cockcroft-Gault equation)
What rules you out
- Prior anti-leukemic therapy for CLL or SLL
- Received live, attenuated vaccine within 4 weeks of randomization
- History of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic condition that in the opinion of the investigator would adversely affect a subject's participation in the study
- Currently active, clinically significant Child-Pugh Class B or C hepatic impairment according to the Child Pugh classification
- Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Inability or difficulty swallowing capsules/tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
- Presence of del17p or known TP53 mutation detected at a threshold of >10% variable allele frequency (VAF)
- Major surgery within 4 weeks of first dose of study treatment
- Known bleeding disorders (eg, von Willebrand's disease or hemophilia)
- Central nervous system (CNS) involvement or suspected Richter's syndrome
- An individual organ/system impairment score of 4 as assessed by CIRS, except for the eyes, ears, nose, throat, and larynx system, limiting the ability to receive treatment in this study
- Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia (Coombs positivity in the absence of hemolysis is not an exclusion)
- Chronic use of corticosteroids more than 20 mg/day of prednisone or its equivalent within 7 days of initiation of study treatment
- History of prior malignancy, except: a. Malignancy treated with curative intent and with no known active disease present for ≥24 months before randomization; b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c. Adequately treated cervical carcinoma in situ without evidence of disease; d. Malignancy, which is considered cured with minimal risk of recurrence
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Turkey
- United States
- Russian Federation
- Israel
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 United Kingdom; Canada; Turkey; United States; Russian Federation; Israel. 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.