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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
AbbVie
Study ID
NCT03406156
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    Administered via intravenous infusion
  • Bendamustine — DRUG
    Administered via intravenous infusion
  • Venetoclax — DRUG
    The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Venetoclax was continued for a total duration of up to 53 weeks, including the 5-week ramp-up schedule. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.

Study Details

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.

Key Dates

Start date
Aug 10, 2018
Status verified
Jul 2024
Primary completion
Oct 12, 2021
Completion
Jul 12, 2023

Study Design

Enrollment
120 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab
    Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.
  • Experimental: Obinutuzumab/bendamustine
    Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m\^2 ) was to be administered to those with nodes or nodal mass \> 10 cm, or with del(11q) and \> 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.

Primary Outcome Measure

Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) [ Time Frame: From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug ]

Locations (15)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC-HOPE /ID# 202335TempeArizona85284-1812-
Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328DenverColorado80218-
MidAmerica Division, Inc. /ID# 201099Kansas CityMissouri64132-
Oncology Hematology Care, Inc. /ID# 202397CincinnatiOhio45236-2725-
Willamette Valley Cancer Institute and Research Center /ID# 201201EugeneOregon97401-6043-
Prisma Health Cancer Inst - Eastside /ID# 202329GreenvilleSouth Carolina29615-
Tennessee Oncology - Chattanooga /ID# 202840ChattanoogaTennessee37404-1108-
Tennessee Oncology-Nashville Centennial /ID# 201098NashvilleTennessee37203-1632-
Texas Oncology - Austin Midtown /ID# 201199AustinTexas78705-
Texas Oncology - Beaumont /ID# 202359BeaumontTexas77701-4691-
Texas Oncology - Medical City Dallas /ID# 201196DallasTexas75230-
Texas Oncology - McAllen /ID# 202331McAllenTexas78503-
Texas Oncology - San Antonio Medical Center /ID# 202332San AntonioTexas78240-5251-
Texas Oncology - Northeast Texas /ID# 201211TylerTexas75702-
Northwest Cancer Specialists, P.C. /ID# 201198VancouverWashington98684-

Find similar trials in Tempe, AZ

By research site
Arizona Oncology Associates, PC-HOPE· Tempe, AZRocky Mountain Cancer Centers - Denver Midtown· Denver, COMidAmerica Division, Inc.· Kansas City, MOOncology Hematology Care, Inc.· Cincinnati, OHWillamette Valley Cancer Institute and Research Center· Eugene, ORPrisma Health Cancer Inst - Eastside· Greenville, SC

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