Health Trials

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.

ConditionsChronic Lymphocytic Leukaemia (CLL)Small Lymphocytic Lymphoma (SLL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVitebsk Regional Clinical Cancer Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented CD19+ CLL or SLL

Patients must have failed at least 1 prior regimen

Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity

ECOG Performance status 0 or 1

Disqualifiers

CLL patients with known or suspected transformed disease (i.e. Richter's transformation).

Pregnant or lactating women.

Uncontrolled active infection.

Active hepatitis B or hepatitis C infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lenalidomide

    Drug

    Lenalidomide 10mg per os 0- 6 days

  • Lenalidomide

    Drug

    Lenalidomide 10 mg per os 1 -14 days

  • Obinutuzumab Injection [Gazyva]

    Biological/Vaccine

    Combined with Lenalidomide 10 mg per os 1- 14 days for 6 cycles

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Low dose antiCD19 CAR T-cells plus LenalidomideExperimental treatment 2 interventions
Group B: Medium dose of antiCD19 CAR T-cell therapy plus LenalidomideExperimental treatment 2 interventions
Group C: High dose antiCD19 CAR T-cell therapy plus LenalidomideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse events incidence

Time frame
24 months
2

Safety

* To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability. * To explore the pharmacokinetics of CAR-T cells.

Time frame
24 months

Secondary outcomes

1

Efficacy

Time frame
- Overall response rate, including complete response (CR) and partial response (PR) rates. - Progression-free survival rates. - Overall survival rates. - MRD negativity rates measured by flow cytometry.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vitebsk Regional Clinical Cancer Centre

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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