A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

Study Identifier
M16-788
CT.gov Identifier
NCT03406156
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
    • Study Drug
  • Obinutuzumab
  • Bendamustine
  • Venetoclax
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Adequate hematology, kidney and liver function as described in the protocol * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1 * CLL/SLL requires treatment according to the IWCLL criteria * Medium tumor burden (any lymph node \[LN\] 5 to \< 10 cm OR absolute lymphocyte count \[ALC\] ≥ 25 × 10\^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10\^9/L and LN ≥ 5 cm)
    Exclusion Criteria:
    * Presence of 17p deletion at Screening * Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma) * Prolymphocytic leukemia

    Protocol Summary

    This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.

    Study Locations

    Location
    Status
    Location
    Arizona Oncology Associates, PC-HOPE /ID# 202335
    Tempe, Arizona, United States, 85284-1812
    Status
    Not applicable
    Location
    Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328
    Denver, Colorado, United States, 80218
    Status
    Not applicable
    Location
    MidAmerica Division, Inc. /ID# 201099
    Kansas City, Missouri, United States, 64132
    Status
    Not applicable
    Location
    Oncology Hematology Care, Inc. /ID# 202397
    Cincinnati, Ohio, United States, 45236-2725
    Status
    Not applicable
    Location
    Willamette Valley Cancer Institute and Research Center /ID# 201201
    Eugene, Oregon, United States, 97401-6043
    Status
    Not applicable
    Location
    Prisma Health Cancer Inst - Eastside /ID# 202329
    Greenville, South Carolina, United States, 29615
    Status
    Not applicable
    Showing {first} - {last} of {total} Results