OncoMatch/Clinical Trials/NCT04269902
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Is NCT04269902 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Obinutuzumab and Venetoclax for chronic lymphocytic leukemia.
Treatment: Obinutuzumab · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
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)
Allowed: IGHV mutation analysis
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
Allowed: 13Q abnormality
FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
Allowed: 12 abnormality
FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
Allowed: 11Q abnormality
FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
Allowed: 17P abnormality
FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-CD20 monoclonal antibody
Prior therapy with anti CD20 monoclonal antibodies is not allowed
Cannot have received: CLL-directed therapy
Exception: agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 [COVID-19]
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
Lab requirements
Blood counts
Platelet count >= 100,000/mm^3; Absolute neutrophil count (ANC) >= 1,000/mm^3
Kidney function
Creatinine clearance >= 30mL/min (by Cockcroft Gault)
Liver function
AST and ALT < 3.0 x upper limit of normal (ULN); total bilirubin <= 2.0 x ULN (or 5.0 x ULN if history of Gilbert's disease)
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; AST and 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Minneapolis VA Medical Center · Minneapolis, Minnesota
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04269902 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify