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New treatment option for Chronic Lymphocytic Leukemia
Official title Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
ClinicalTrials.gov ID: NCT03516617
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 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 trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. 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
- Time commitment: about 10 years
- 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
- Age \>= 18 years
- Diagnosis of:
- Biopsy-proven small lymphocytic lymphoma (SLL) , or
- Diagnosis of chronic lymphocytic leukemia (CLL) with a clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL as...
- The population of lymphocytes share both B-cell antigens (CD19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other...
You likely can't join if
- Date of CLL/SLL diagnosis \>= 24 months prior to registration
- Prior exposure to ibrutinib or to a BCR inhibitor (e.g. Btk or PI3 kinase or Syk inhibitors) or a BCL-2 inhibitor (e.g. venetoclax)
- Known central nervous system (CNS) lymphoma or leukemia
- Patients with any of the following indications for chemotherapy:
- Evidence of progressive marrow failure as manifested by the development of or worsening anemia (=\< 11 g/dL) and/or thrombocytopenia (=\< 100 x...
- Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
See the full eligibility criteria
Who can join
- Age \>= 18 years
- Diagnosis of:
- Biopsy-proven small lymphocytic lymphoma (SLL) , or
- Diagnosis of chronic lymphocytic leukemia (CLL) with a clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL as follows:
- The population of lymphocytes share both B-cell antigens (CD19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.)
- Clonality as evidenced by kappa or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis)
- Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(11;14)(IgH/CCND1)
- Patients must be previously untreated
- Note: Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL or SLL will be considered prior therapy; nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate...
- All patients will undergo testing for prognostic factors according to the CLL-IPI (testing obtained =\< 730 days prior to registration)
- Note: If the results for any of the prognostic factors included in the CLL-IPI are unknown including IGVH mutation status results not being available due to a failed laboratory assay, the patient is not eligible
- Note: When determining CLL-IPI, use most recent test results, if more than one result is available
- Note: Patients with CLL-IPI risk category of high risk or very high risk (total score of 4-10) will be assigned by chance to Arms A or B
- Note: Patients with CLL-IPI risk category of low risk or intermediate risk (total score of 0-3) will be registered to Arm C
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Provide written informed consent
- Willing to provide blood and saliva samples for correlative research purposes
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 30 days prior to randomization)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Platelet count \>= 100,000/mm\^3 (obtained =\< 30 days prior to randomization)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Hemoglobin \>= 11.0 g/dL (obtained =\< 30 days prior to randomization)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Aspartate aminotransferase (aspartate transaminase [AST]) =\< 3 x upper limit of normal (ULN) (obtained =\< 30 days prior to randomization)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Creatinine =\< 1.5 X ULN (obtained =\< 30 days prior to randomization)
- For high risk and very high risk CLL-IPI (Arms A and B) only: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (or total bilirubin =\< 3.0 x ULN with direct bilirubin =\< 1.5 x ULN in patients with well-documented...
- For high risk and very high risk CLL-IPI (Arms A and B) only: Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =\< 1.5 X ULN OR if patient is receiving anticoagulant...
- Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
- Will provide bone marrow aspirate sample for correlative research purposes
What rules you out
- Date of CLL/SLL diagnosis \>= 24 months prior to registration
- Prior exposure to ibrutinib or to a BCR inhibitor (e.g. Btk or PI3 kinase or Syk inhibitors) or a BCL-2 inhibitor (e.g. venetoclax)
- Known central nervous system (CNS) lymphoma or leukemia
- Patients with any of the following indications for chemotherapy:
- Evidence of progressive marrow failure as manifested by the development of or worsening anemia (=\< 11 g/dL) and/or thrombocytopenia (=\< 100 x 10\^9/L) not due to autoimmune disease
- Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
- One or more of the following disease-related symptoms:
- Weight loss \>= 10% within the previous 6 months
- Extreme fatigue attributed to CLL
- Fevers \>= 100.4 degrees Fahrenheit (F) for 2 weeks without evidence of infection
- Drenching night sweats without evidence of infection
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are...
- 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...
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =\< 2 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or early stage prostate cancer
- History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- For high risk and very high risk CLL-IPI (Arms A and B) only:
- Any of the following:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ highly effective contraception
- Serologic status reflecting active hepatitis B or C infection
- NOTE: people with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomization...
- History of stroke or intracranial hemorrhage within 6 months before randomization
- History of bleeding diathesis (e.g. hemophilia, von Willebrand disease)
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug and while on study
- Requires treatment with a strong CYP3A inducer
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Received a vaccination with a live vaccine =\< 28 days prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, 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 study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, 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.