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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
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 9, 2026 → Aug 9, 2026
Primary endpoint added 1 → 2 primary endpoints
Enrollment reduced 60% 60 → 24 participants
See other at-risk trials from Vitebsk Regional Clinical Cancer Centre

Record History

  1. Start date: Nov 4, 2024 to May 14, 2024v3
  2. Primary endpoint(s) modified Enrollment reduced: 60 → 24 participants · Trial status changed: Enrolling by Invitation → Recruiting · Primary completion pushed from Mar 9, 2026 to Aug 9, 2026 · 5 morev2 Show 8 more changesShow less
    • Enrollment reduced: 60 → 24 participants
    • Trial status changed: Enrolling by Invitation → Recruiting
    • Primary completion pushed from Mar 9, 2026 to Aug 9, 2026
    • Trial arms changed: 4 → 3
    • Interventions: Lenalidomide (Drug), Lenalidomide (Drug) to Lenalidomide (Drug), Lenalidomide (Drug), Obinutuzumab Injection [Gazyva] (Biological)
    • Study description expanded, about 25 words
    • Site details revised
    • Secondary endpoints expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov