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NCT06762431 · ClinicalTrials.gov record · last posted 2026-08-13

Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.

Study acronym: VTB-CLL002
StatusRecruiting
PhasePhase 1/2
Started2024-05-14
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This is a Phase I/II interventional, open-label treatment study designed to evaluate the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.

Protocol amendment history 5 changes detected by DataLookout

2026-08-11
Trial status changed: Enrolling by Invitation → Recruiting
2026-08-11
Primary endpoint(s) modified
WasAdverse events incidence
NowAdverse events incidence, Safety
2026-08-11
Enrollment reduced: 60 → 24 participants
2026-08-11
Trial arms changed: 4 → 3
2026-08-11
Primary completion pushed: 2026-03-09 → 2026-08-09
Trial Details
NCT Number NCT06762431
Lead Sponsor Vitebsk Regional Clinical Cancer Centre
Collaborators: Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology
Conditions Chronic Lymphocytic Leukaemia (CLL), Small Lymphocytic Lymphoma (SLL)
Enrollment 24 participants
Start Date 2024-05-14
Primary Completion 2026-08-09 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-13