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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.

NCT06762431 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Lymphocytic Leukaemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Interventions

DRUG

Lenalidomide

Dose Level 1

DRUG

Lenalidomide

Dose Level 2

Sponsors & Collaborators

  • Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology

    collaborator UNKNOWN

  • Vitebsk Regional Clinical Cancer Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-03-09
Completion
2026-08-31

Countries

  • Belarus

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762431 on ClinicalTrials.gov