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New treatment option for Chronic Lymphocytic Leukemia
Official title Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
ClinicalTrials.gov ID: NCT04560322
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as Venclexta.
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 research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The names of the study drugs involved in this study are: obinutuzumab venetoclax acalabrutinib
- Phase 2: a mid-size study of how well it works
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
- Diagnosis of CLL or SLL according to WHO criteria
- Participants must require therapy according to iwCLL 2018 guidelines
- Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL BALL Risk Model:
- Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point
- Lactate dehydrogenase If \>institutional upper limit of normal, assign 1 point
You likely can't join if
- Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception:
- Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or...
- Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
- Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator
- Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)
- Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection...
See the full eligibility criteria
Who can join
- Diagnosis of CLL or SLL according to WHO criteria
- Participants must require therapy according to iwCLL 2018 guidelines
- Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL BALL Risk Model:
- Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point
- Lactate dehydrogenase If \>institutional upper limit of normal, assign 1 point
- Hemoglobin If \<11 g/dL (female) or \<12 g/dL (male), assign 1 point
- Time from start of last therapy If \<24 months, assign 1 point, If 4 points, patient is high risk, If 2-3 points, patient is intermediate risk, If 0-1 points, patient is low risk
- Participants must have received prior systemic therapy for CLL
- Age over 18 years
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Participants must have adequate organ function as defined below:
- total bilirubin ≤2 × institutional upper limit of normal unless considered secondary to Gilbert's syndrome, in which case ≤3 x ULN
- AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥30 mL/min according to the Cockcroft-Gault Equation for participants with creatinine levels above institutional normal.
- Participants must have adequate marrow function as defined below (unless clearly due to disease under study per investigator discretion)
- absolute neutrophil count ≥1,000/mcL
- platelets ≥75,000/mcL OR
- \> 20,000/mcL if thrombocytopenia is clearly due to disease under study (per investigator discretion).
- For females of childbearing potential, a negative serum pregnancy test within 7 days of study treatment
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in...
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- Willingness to not donate sperm or oocytes during the entire study treatment period and after treatment discontinuation
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception:
- Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK...
- Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
- Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator
- Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)
- Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted; active...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV...
- Known bleeding diathesis
- Pregnant women are excluded from this study because the study agents have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants...
- Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study
- Known CNS hemorrhage or stroke within 6 months of the study
- History of progressive multifocal leukoencephalopathy (PML)
- History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection
- Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate...
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- Congestive heart failure, New York Heart Association classification III/IV
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
- Known condition or other clinical situation that would affect oral absorption
- Psychiatric illness/social situations that would interfere with study compliance
- Receipt of therapy with strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9 and CYP2C19, within 7 days prior to the first dose of study drug administration
- Consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug administration.
- Requires dual antiplatelet therapy or anticoagulation with warfarin
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 Boston, Massachusetts, 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.