The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Stanford, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04447768
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    Cycle 1, Day 1- 100 mg Cycle 1, Day 2 - 900 mg Cycle 1, Day 8 - 1000 mg Cycle 1, Day 15 -1000 mg Cycle 2, Day 1 to Cycle 6, Day 1- 1000 mg
  • Venetoclax — DRUG
    Cycle 1, Day 22 to 28 -20 mg daily Cycle 2, Day 1 to Day 7 -50 mg daily Cycle 2, Day 8 to Day 14- 100 mg daily Cycle 2, Day 15 to Day 21- 200 mg daily Cycle 2, Day 22 to Day 28 - 400 mg daily Cycle 3, Day 1 to end of Cycle 12-24 - 400 mg daily

Study Details

This study will help researchers collect more information about how effective the combination of venetoclax and obinutuzumab is in treating CLL in people who have not received a previous treatment for their cancer.

Key Dates

Start date
Dec 3, 2020
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax and Obinutuzumab
    All patients will receive a minimum of 9 cycles (cycle = 28 days) of therapy with venetoclax and obinutuzumab during the treatment period. For patients who remain MRD positive at Cycle 9 of therapy, an additional 12 cycles of venetoclax monotherapy will be given.

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: 36 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford University Medical Center (Data collection only)StanfordCalifornia94305-5408-
Memorial Sloan Kettering Basking Ridge (All protocol activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (All protocol activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Commack (All protocol activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All protocol activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (All protocol activities)UniondaleNew York11553-
University of North CarolinaChapel HillNorth Carolina27514-

Find similar trials in Stanford, CA

By research site
Stanford University Medical Center (Data collection only)· Stanford, CAMemorial Sloan Kettering Basking Ridge (All protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Commack (All protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (All protocol activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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