Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Recruiting now · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Key facts

Study ID: NCT04269902
Run by: National Cancer Institute (NCI)
People needed: 247
Starts: 2021-03-02
Expected to finish: 2028-10-01
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
Participants must have CLL-International Prognostic Index (CLL-IPI) score >= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
Participants must not meet any of the IWCLL specified criteria for active CLL therapy
Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
Prior therapy with anti CD20 monoclonal antibodies is not allowed
Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 [COVID-19]), or radiotherapy
Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
Participants must be >= 18 years of age
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Platelet count >= 100,000/mm\^3 within 28 days prior to registration
Absolute neutrophil count (ANC) >= 1,000/mm\^3 within 28 days prior to registration
Creatinine clearance >= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) within 28 days prior to registration
Total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
Participants must be able to take oral medications
Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy
Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
Participants must not have cirrhosis

Where it is running

City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
Kaiser Permanente-Ontario — Ontario, California, United States (enrolling)
Kaiser Permanente South Bay — Harbor City, California, United States (enrolling)
UCI Health Laguna Hills — Laguna Hills, California, United States (enrolling)
Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
City of Hope Newport Beach — Newport Beach, California, United States (enrolling)
UC Irvine Health Cancer Center-Newport — Costa Mesa, California, United States (enrolling)
Kaiser Permanente-Fontana — Fontana, California, United States (enrolling)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
Kaiser Permanente-Irvine — Irvine, California, United States (enrolling)
City of Hope at Long Beach Elm — Long Beach, California, United States (enrolling)
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
Kaiser Permanente West Los Angeles — Los Angeles, California, United States (enrolling)
Fremont - Rideout Cancer Center — Marysville, California, United States (enrolling)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
Kaiser Permanente-Anaheim — Anaheim, California, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States (enrolling)
Kaiser Permanente-Bellflower — Bellflower, California, United States (enrolling)
City of Hope Seacliff — Huntington Beach, California, United States (enrolling)
Marshall Cancer Center — Cameron Park, California, United States (enrolling)
City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
Enloe Medical Center — Chico, California, United States (enrolling)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)

Full record on ClinicalTrials.gov

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