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

NCT04447768 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20-044
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Venetoclax; Obinutuzumab; 20-044

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  36 months

Secondary Outcomes (1)

• Overall response rate

  2 years

Study Arms (1)

Venetoclax and Obinutuzumab

EXPERIMENTAL

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.

Drug: Obinutuzumab; Drug: Venetoclax

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 and Obinutuzumab

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

Venetoclax and Obinutuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Ability and willingness to comply with the requirements of the study protocol.
• Age ≥18 years.
• Have documented previously untreated chronic lymphocytic leukemia according to iwCLL / WHO criteria.
• Require treatment of CLL per iwCLL guidelines.
• CIRS score ≤ 6 (patient's CLL diagnosis is not included in CIRS score).
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Adequate hematologic function (unless caused by underlying disease, as established by extensive bone marrow involvement or as a result of hypersplenism secondary to the involvement of the spleen by CLL per the investigator) defined as follows:
• Hemoglobin ≥ 8 g/dL without transfusion support, unless anemia is due to marrow involvement of CLL.
• Absolute neutrophil count ≥ 1.0 x 10\^9/L.
• Platelet count ≥ 30 x 10\^9/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be ≥ 10 x 10\^9/L if there is bone marrow involvement.
• Adequate renal function, as indicated by modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \[IBM\] instead of mass) of \> 50mL/min
• Adequate liver function, as indicated by:
• AST or ALT ≤ 2.5 x ULN.
• Total bilirubin ≤ 1.5 x ULN (or ≤ 5 x ULN for patients with documented Gilbert syndrome).

You may not qualify if:

• Prior CLL-directed therapy. Patients may have received a brief (≤7 days) course of systemic steroids prior to initiation of study therapy for control of lymphoma-related symptoms.
• Transformation of CLL to aggressive NHL (Richter's transformation or prolymphocytic leukemia).
• Known hypersensitivity to any of the study drugs.
• History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:
• Malignancies treated with curative intent and with no known active disease within 2 years
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (no time constraint).
• Adequately treated cervical carcinoma in situ without evidence of disease (no time constraint).
• Surgically/adequately treated low grade, early stage, localized prostate cancer without evidence of disease (no time constraint).
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1.
• Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin).
• Received the following agents within 7 days prior to the first dose of venetoclax:
• Strong and moderate CYP3A inhibitors.
• Strong and moderate CYP3A inducers.
• Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax.
• Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (8)

Stanford University Medical Center (Data collection only)

Stanford, California, 94305-5408, United States

Location

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

obinutuzumab; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meghan Thompson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: December 3, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (8)