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New treatment option for Grade 1 Follicular Lymphoma
Official title Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
ClinicalTrials.gov ID: NCT04883437
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for grade 1 follicular lymphoma.
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 the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). 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
- Men and women \>= 18 years of age
- Patients will need to have one of the following clinical scenarios:
- Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard...
- Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor...
You likely can't join if
- The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma
- Confirmed active or prior central nervous system disease
- Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone...
- A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and...
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ...
- Clinically significant cardiovascular disease such as symptomatic ventricular arrhythmias, congestive heart failure, or myocardial infarction within...
See the full eligibility criteria
Who can join
- Men and women \>= 18 years of age
- Patients will need to have one of the following clinical scenarios:
- Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard front-line treatment approaches
- Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor burden by GELF criteria or who are unable/unwilling to receive more...
- Previously untreated mantle cell lymphoma who would otherwise be appropriate candidates for watchful waiting OR who have symptomatic disease but are not candidates for or decline standard induction approaches
- Patients with previously untreated low tumor burden FL (criterion above) must have measurable and/or assessable disease defined as at least one involved lymph node or extranodal disease site that measures \>= 1.5cm in...
- Patients who meet above are eligible as long as they meet one of the following criteria for measurable/assessable disease:
- At least one involved lymph node or extranodal disease site measuring \> 1.5cm in greatest diameter
- Pathologically-confirmed bone marrow or peripheral blood involvement that can be reassessed for response
- Pathologically confirmed splenic or extranodal involvement with at least one known site of disease remaining after diagnostic biopsy that can be reassessed (i.e., patients with splenic marginal zone lymphoma who...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Woman of childbearing potential (WOCBP) and men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study...
- Women of childbearing potential must have a negative serum or urine pregnancy test prior to starting therapy
- Willing and able to participate in all required evaluations and procedures in this study protocol
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information Ability to understand the purpose and risks of the study and...
What rules you out
- The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma
- Confirmed active or prior central nervous system disease
- Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone lymphoma such as hepatitis C or H pylori)
- A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and steroids must be discontinued (or tapered to =\< 10mg prednisone or...
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been...
- Clinically significant cardiovascular disease such as symptomatic ventricular arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined...
- Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
- Known history of human immunodeficiency (HIV) or any active significant infection (e.g., bacterial, viral, or fungal) within 14 days of cycle 1. Patients with uncomplicated viral or bacterial infections that are being...
- Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with proton pump inhibitors (e.g, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: people receiving proton pump inhibitors who switch to H2-receptor...
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug. Patients with a transient ischemic attack which has resolved and...
- Major surgical procedure within 28 days of first dose of study drug (not including a diagnostic procedure to make the lymphoma diagnosis). Note: If a subject had major surgery, they must have recovered adequately from...
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and...
- Absolute neutrophil count (ANC) \< 1,000/mcL
- Platelet count \< 50,000/mcL (Unless felt to be related to underlying disease)
- Total bilirubin \>= 1.5 x the upper limit of normal (ULN). Isolated bilirubin \> 1.5 x ULN is permitted if the direct proportion is \< 35%
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN
- Creatinine clearance =\< 40 mL/min/1.73m\^2
- Breastfeeding or pregnant
- Concurrent participation in another therapeutic clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, 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 Atlanta, Georgia, 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.