Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Pirtobrutinib in Combination With Epcoritamab if the Disease Comes Back After Previous Treatment.

ConditionCLL / SLL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStichting Hemato-Oncologie voor Volwassenen Nederland

About this trial

The Haemato Oncology Foundation for Adults in the Netherlands (HOVON) has designed this study. Researchers (all doctors) are conducting the study at various hospitals in the Netherlands, Denmark and Sweden.

The study medicines pirtobrutinib and epcoritamab that are used in this study are made available by pharmaceutical companies Eli Lilly and AbbVie. This study is also funded by AbbVie and Eli Lilly.

HOVON needs 70 participants for this study.

The purpose of this study is to find out how safe and effective the combination of pirtobrutinib tablets and subcutaneous epcoritamab is for patients with CLL whose disease has come back after previous treatment or whose disease did not respond well to the previous treatment. The goal is to suppress the CLL to such an extent that the disease does not come back for a long time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented relapsed or refractory CLL or SLL (SLL in Cohort Expansion only) following at least one systemic 1st-line treatment

Requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria;

Age at least 18 years;

Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • pirtobrutinib combined with epcoritamab

    Combination product

    combination treatment

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Pirtobrutinib combined with epcoritamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate efficacy in terms of Progression-free survival (PFS)

To evaluate efficacy in terms of Progression-free survival (PFS) at 24 months after first dose of pirtobrutinib.

Time frame
24 months after first dose of pirtobrutinib.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: