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New treatment option for Recurrent Chronic Lymphocytic Leukemia
Official title Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
ClinicalTrials.gov ID: NCT04169737
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent chronic lymphocytic leukemia.
Also referred to as ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a diagnosis of CLL/SLL and indication for treatment by 2018 iwCLL criteria: Cohort 1: Untreated patients with at least 1 high-risk...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Adequate renal and hepatic function:
- Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease
You likely can't join if
- Prior treatment with combined BTKi and BCL2i where patients do not achieve at least partial response or progress and need new treatment within 2...
- Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, investigational therapy or live virus vaccination within 3 weeks prior to...
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Uncontrolled clinically significant active infection (viral, bacterial, and fungal)
- Known positive serology for human immunodeficiency virus (HIV), due to potential drug-drug interactions between anti-retroviral medications and the...
- Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). people with serologic evidence of prior...
See the full eligibility criteria
- Patients with a diagnosis of CLL/SLL and indication for treatment by 2018 iwCLL criteria: Cohort 1: Untreated patients with at least 1 high-risk feature (del(17p) or mutated TP53 or del(11q) or unmutated IGHV or complex...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Adequate renal and hepatic function:
- Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease
- Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, MDRD, or CKD-EPI formula)
- ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement
- Absolute neutrophil count greater than 750 neutrophils/L, unless thought to be due to marrow infiltration with CLL. Platelet count of greater than 30,000/µl, with no platelet transfusion in 2 weeks prior to registration...
- Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use an effective...
- Free of prior malignancies for 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast, who are eligible even if they are...
- Patients must provide written informed consent.
- Prior treatment with combined BTKi and BCL2i where patients do not achieve at least partial response or progress and need new treatment within 2 years of completing fixed-duration combined treatment.
- Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, investigational therapy or live virus vaccination within 3 weeks prior to the first dose of the study drugs, unless patients have rapidly...
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Uncontrolled clinically significant active infection (viral, bacterial, and fungal)
- Known positive serology for human immunodeficiency virus (HIV), due to potential drug-drug interactions between anti-retroviral medications and the study drugs
- Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). people with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc...
- Active hepatitis C, defined by the detectable hepatitis C RNA in plasma by PCR
- Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \>20mg daily of prednisone dose or equivalent
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the...
- Patient is pregnant or breast-feeding
- Concurrent use of warfarin
- Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting study drugs and throughout venetoclax administration
- Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting venetoclax
- Known bleeding disorder or history of stroke or intracranial hemorrhage within past 6 months
- Malabsorption syndrome or other condition that precludes enteral route of administration
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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 ClinicalTrials.gov; the study team decides eligibility.