NCT04269902

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 Last updated 15 April 2026

What this trial tests

Phase 3 trial testing Biospecimen Collection in Chronic Lymphocytic Leukemia in 247 participants. Currently enrolling.

Timeline

2 March 2021

Primary endpoint
1 October 2028

1 October 2028

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	247
Start date	2 March 2021
Primary completion	1 October 2028
Estimated completion	1 October 2028
Sites	628 locations across Canada, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Bone Marrow Aspiration — full drug profile →
• Bone Marrow Biopsy
• Computed Tomography
• Obinutuzumab — full drug profile →
• Questionnaire Administration
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Small Lymphocytic Lymphoma — all drugs for Small Lymphocytic Lymphoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cause of death in patients with newly diagnosed chronic lymphocytic leukemia (CLL) stratified by the CLL-International Prognostic Index.
   Wang Y, Achenbach SJ, Rabe KG, Shanafelt TD, et al · · 2021 · cited 16× · PMID 34354039 · DOI 10.1038/s41408-021-00532-1
2. Consensus recommendations from the 2024 Lymphoma Research Foundation workshop on treatment selection and sequencing in CLL or SLL.
   Soumerai JD, Barrientos J, Ahn I, Coombs C, et al · · 2025 · cited 10× · PMID 39561376 · DOI 10.1182/bloodadvances.2024014474
3. Overcoming barriers to drug development and enrollment in clinical trials for adolescents and young adults with lymphoma.
   Toner K, Allen CE, Jain S, Kahl B, et al · · 2023 · cited 2× · PMID 38024612 · DOI 10.1002/jha2.787
4. Clinical Outcomes in a Large Canadian Centralized CLL Clinic Based on Treatment and Molecular Factors over a Decade.
   Yang J, Yang L, Tordon B, Bucher O, et al · · 2023 · cited 2× · PMID 37504332 · DOI 10.3390/curroncol30070472
5. Consensus in CLL: global needs matter.
   Shadman M, Fakhri B, Jain N. · · 2025 · cited 1× · PMID 40067336 · DOI 10.1182/bloodadvances.2024015355
6. State of the art biology, progression, and clinical management of monoclonal B-cell lymphocytosis (MBL): consensus report from the Intercepting Blood Cancers Workshop Committee.
   Ryan CE, Ahn IE, Sekar A, Rawstron A, et al · · 2025 · PMID 40883275 · DOI 10.1038/s41408-025-01341-6