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Clinical Trials in Canada / NCT01886872
Active, not recruiting Phase 3

Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT01886872 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2014-01-15
Last updated
2026-08-28

Condition(s) studied

Stage I Chronic Lymphocytic LeukemiaStage II Chronic Lymphocytic LeukemiaStage III Chronic Lymphocytic LeukemiaStage IV Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

Bendamustine Hydrochloride →Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyIbrutinib →Laboratory Biomarker AnalysisQuality-of-Life AssessmentRituximab →

Bendamustine Hydrochloride: Given IV

Biospecimen Collection: Undergo blood sample collection

Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy

Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy

Computed Tomography: Undergo CT

Ibrutinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Rituximab: Given IV

Study summary

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * PRE-REGISTRATION (STEP 0) * All patients are REQUIRED to be pre-registered to A041202 in order to submit peripheral blood to the Alliance Hematologic Malignancy Biorepository (HEME) for central Zap-70 methylation. This specimen submission is mandatory prior to registration as results will be used for stratification * REGISTRATION (STEP 1) * Patients must be diagnosed with CLL in accordance with International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria that includes all of the following: * \>= 5 x 10\^9 B lymphocytes (5000/uL) in the peripheral blood * On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes * CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in \> 10% of cells must lack t(11;14) translocation by interphase cytogenetics * Patients must be intermediate or high-risk Rai stage CLL * Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly * High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin \< 11 g/dL) or thrombocytopenia (platelet count \< 100 x 10\^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia * Patients must meet criteria for treatment as defined by IWCLL 2008 guidelines which includes at least one of the following criteria: * Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia) * Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly * Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy * Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy * Constitutional symptoms, which include any of the following: * Unintentional weight loss of 10% or more within 6 months * Significant fatigue * Fevers \> 100.5 degrees F for 2 weeks or more without evidence of infection * Night sweats \> 1 month without evidence of infection * Prior treatment * Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids) * Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration * Age \>= 65 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician * Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician * Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment * Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible * Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible * Patients with known human immunodeficiency virus (HIV) are eligible if their CD4 count is \>= 350 cells/mm\^3 and if they are not taking prohibited CYP-interacting medications * Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood \> 55%) * Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily * Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics * Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer * Patients must not have a known allergy to mannitol * Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions) * Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician * Absolute neutrophil count (ANC) \>= 1,000/uL unless due to bone marrow involvement * Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =\< 2.5 x upper limits of normal except if due to disease infiltration of the liver * Bilirubin =\< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert's disease) * Creatinine clearance \>= 40 mL/min * To be calculated by modified Cockcroft-Gault formula * Platelet count (untransfused) \>= 30,000/uL

Primary outcome measure(s)

Trial sites (937)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Regional Hospital Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Mayo Clinic Hospital in Arizona Phoenix Arizona
Mayo Clinic in Arizona Scottsdale Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Onvida Health Yuma Medical Center Yuma Arizona
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
Kaiser Permanente-Anaheim Anaheim California
Kaiser Permanente-Deer Valley Medical Center Antioch California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mills-Peninsula Medical Center Burlingame California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
John Muir Medical Center-Concord Concord California
Sutter Davis Hospital Davis California
City of Hope Comprehensive Cancer Center Duarte California
Kaiser Permanente-Fontana Fontana California
Kaiser Permanente-Fremont Fremont California
Kaiser Permanente-Fresno Fresno California
Marin Cancer Care Inc Greenbrae California
Marin General Hospital Greenbrae California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California

+ 897 more sites — see the full list on the official registry below.

On this site

📄 Imbruvica (ibrutinib) drug profile → 📄 Rituxan (rituximab) drug profile →

More National Cancer Institute (NCI) trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01886872 on ClinicalTrials.gov ↗ ← All trials in Canada