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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia.
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (> or = 70 Years of Age) With Chronic Lymphocytic Leukemia (CLL).
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym KP IRB No.
1408476
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals clinically diagnosed with chronic lymphocytic leukemia;
 
Purpose
This is a phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax 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. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
 
Detailed Description
To compare the progression-free survival (PFS) between control treatment and experimental treatment strategies. ibrutinib/obinutuzumab (IO) with ibrutinib maintenance (IM) versus ibrutinib/venetoclax/obinutuzumab (IVO) regardless of IM or observation.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
  • Patients must have been diagnosed with chronic lymphocytic leukemia (CLL) and have >/= 5000 B-cells per uL of peripheral blood at any point during the course of their disease
  • This blood submission is mandatory prior to registration/randomization to perform fluorescence in situ hybridization (FISH) centrally that will be used for stratification. It should be obtained as soon after pre-registration as possible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
  • Patients must be diagnosed with CLL in accordance with 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria that includes all of the following
  • >/= 5 x10^9 B lymphocytes (5000/uL) in the peripheral blood measured by flow cytometry at any point in the course of the disease
  • On local 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
  • "Please contact study team for more eligibility criteria."
 
Exclusion Criteria
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
  • Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood >/= 55%)
  • 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 must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed. Patients must discontinue the drug 14 days prior to registration on the study
  • 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 be able to swallow capsules and not have the following conditions: disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction
  • Patients must not have a known allergy to mannitol
  • "Please contact study team for more eligibility criteria."

 
Keywords and/or Specific Medical Conditions
  • Antineoplastic Agents
  • Lymphatic Diseases
  • Antineoplastic Agents, Immunological
  • Lymphoproliferative Disorders
  • Antirheumatic Agents
  • Neoplasms
  • Immune System Diseases
  • Neoplasms by Histologic Type
  • Immunologic Factors
  • Obinutuzumab
  • Immunoproliferative Disorders
  • Physiological Effects of Drugs
  • Leukemia
  • Rituximab
  • Leukemia, B-Cell
  • Venetoclax
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Oncology (Adult)
  • Leukemia, Lymphoid
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex Menter, MD
Contact Information:
- Kristi M Bronkan, PharmD
-303-720-2685
-Lone Tree Medical Offices - Lone Tree
-http://kpco-ihr.org/Research/Clinical_Trials.html


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