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A041702


Title A041702: A Randomized Phase III Study of Ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (> 70 years of age) with Chronic Lymphocytic Leukemia
Therapeutic Area Leukemia
Principal Investigator Andreas Klein
Min Age 70 Years
Gender Male or Female
Contact NCCCR
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03737981?term=A041702&draw=2&rank=1

Overview

This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. 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.

Study Details

Inclusion Criteria

  1. Documented diagnosis of CLL

  2. No prior therapy for CLL, except palliative steriods or treatment of autoimmune complications of CLL with rituximab or steroids.

  3. Age 70+ years old

Exclusion Criteria

  1. Patients must not have any history of Richter’s transformation or prolymphocytic leukemia

  2. Patients must not have evidence of chronic infections, e.g. Hep B, Hep C

  3. Patients who have had a heart attack or stroke within the past 6 months

Study Requirements

  1. Patients must not hve any history of Richter’s transformation or prolymphocytic leukemia

  2. Patients must not have evidence of chronic infections, e.g. Hep B, Hep C

  3. Patients who have had a heart attack or stroke within the past 6 months