Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Launched by NATIONAL CANCER INSTITUTE (NCI) · Feb 13, 2020
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
**Summary of the EVOLVE CLL/SLL Study**
The EVOLVE CLL/SLL study is a clinical trial designed to find out if starting treatment for high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) earlier—before patients show any symptoms—can lead to better health outcomes. This trial compares two groups: one that receives early treatment with a combination of venetoclax (a medication that stops cancer cells from surviving) and obinutuzumab (an immunotherapy that helps the body fight cancer) right away, and another that waits to start treatment until symptoms appear. The hope is that early treatment will be more effective in controlling the disease.
To participate in this study, patients must have been diagnosed with high-risk CLL or SLL within the last 18 months and meet certain health criteria, including specific test results that indicate a higher risk for their disease. Eligible participants should be at least 18 years old and generally healthy enough to manage the treatment. Those who join the trial can expect regular check-ups and monitoring throughout the study. It’s important to note that this is a research study, so participants will be closely watched to gather data that could help improve treatment options in the future. If you're interested in learning more or think you might qualify, please discuss it with your healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 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 requiring no more than chronic hormonal therapy, or localized breast cancer 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
- • Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
- * Active infection with hepatitis B or C:
- • Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
- * Latent infection with hepatitis B:
- * Latent infection is defined as meeting all of the following criteria:
- • Hepatitis B surface antigen positive
- • Anti-hepatitis B total core antibody positive
- • Anti-hepatitis IgM core antibody undetectable
- • Hepatitis B PCR undetectable
- • Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
- • Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
- • Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
- • Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- • Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
- • Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
- • Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
- • Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
- • Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
- • Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- • Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
- • Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
- • NOTE: With participant's consent, the site must follow through with specimen submission as outlined
- • Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
- • Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
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Shelby, Michigan, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Carmichael, California, United States
Irvine, California, United States
Shreveport, Louisiana, United States
Kalamazoo, Michigan, United States
Oneida, New York, United States
Oswego, New York, United States
Canton, Ohio, United States
Richardson, Texas, United States
Melrose Park, Illinois, United States
Homer Glen, Illinois, United States
Missoula, Montana, United States
Charleston, South Carolina, United States
Edinburg, Texas, United States
Torrance, California, United States
Greeley, Colorado, United States
Newport Beach, California, United States
Nampa, Idaho, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Grand Island, Nebraska, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Long Beach, California, United States
Sheboygan, Wisconsin, United States
Bellevue, Washington, United States
Laguna Hills, California, United States
Kansas City, Missouri, United States
Seattle, Washington, United States
Seattle, Washington, United States
Bellevue, Washington, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Lebanon, New Hampshire, United States
Cameron Park, California, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Webster, New York, United States
Danville, Illinois, United States
Huntington Beach, California, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Brunswick, Maine, United States
Verona, New York, United States
Verona, New York, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lincoln, Nebraska, United States
Lansing, Michigan, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Loveland, Colorado, United States
Rockford, Illinois, United States
Hays, Kansas, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Kinston, North Carolina, United States
Kirkland, Washington, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Huntington Beach, California, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Kenansville, North Carolina, United States
Richlands, North Carolina, United States
Irvine, California, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Camillus, New York, United States
Lafayette, Colorado, United States
Southfield, Michigan, United States
Madison, Wisconsin, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
Norton, Virginia, United States
Bristol, Virginia, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Harbor City, California, United States
Denver, Colorado, United States
Olathe, Kansas, United States
Grosse Pointe Woods, Michigan, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
South Portland, Maine, United States
Portland, Maine, United States
Ballwin, Missouri, United States
Patients applied
Trial Officials
Deborah M Stephens
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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