Summary of UK CLL Clinical Trials Portfolio ~ October 2023:

Compiled with the assistance of Dr S Iyengar, Consultant Haematologist, Royal Marsden Hospital.

	Currently Open or soon to Open Trials
Frontline	BGB-11417-301, Phase 3, Open-label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia. MK-1026-011, Phase 3, Open-label, randomized study of Nemtabrutinib (MK-1026) vs Acalabrutinib in untreated CLL.
Stage A CLL / MBL	OxPLoreD Observational Study
Richter’s Transformation Frontline and relapsed	STELLAR: CHOP-R vs CHOP-R in combination with ACP-196 (Blood Cancer UK sponsored TAP Trial) Phase 2 Study of reversible BTK inhibitor Nemtabrutinib (MK-1026) in Participants with Hematologic Malignancies (for relapsed disease). A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies. Safety and Efficacy Study of Epcoritamab (CD3-CD20 bispecific) in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome (EPCORE™ CLL-1)
Relapsed/Refractory CLL	A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (BRUIN CLL-322) Phase 2 Study of MK-1026 in Participants with Hematologic Malignancies (for relapsed disease). A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies. A Study of BTK degrader NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies Safety and Efficacy Study of Epcoritamab (CD3-CD20 bispecific) in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome (EPCORE™ CLL-1) A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies PRT2527-02 Phase 1, open-label, multicenter, dose-finding study to evaluate the safety, tolerability, recommended phase 2 dose (R2PD), and preliminary efficacy of CDK9 inhibitor PRT2527 in patients with select B-cell malignancies. A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies M23-647 study- ABbvie BTK degrader: First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies
Long term treatment	STATIC: A Randomised Phase III Trial Comparing Intermittent with Continuous Treatment Strategies in Chronic Lymphocytic Leukaemia (CLL).

STELLAR

A Phase II, randomised study of CHOP-R in combination with Acalabrutinib (an oral BTK inhibitor) compared to CHOP-R in patients with newly diagnosed Richter’s Syndrome (RS) followed by an extension study to evaluate Acalabrutinib and other novel therapies in relapsed/refractory RS

The trial is managed by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

This research is being funded by Blood Cancer UK as part of the Trials Acceleration Program (TAP) and by Acerta Pharma.

OxPLoreD Study

This is a study to identify the clinical, genomic and immunological predictive markers of progression to malignant disease.

It will be open to individuals diagnosed in the last 2 years with Binet Stage A CLL.

The study will also include participants with high count MBL, IgG/ IgG/ IgM MGUS, asymptomatic WM not requiring treatment, and smouldering myeloma not requiring treatment.

The study does not involve any treatment and is being undertaken by the University of Oxford. Currently recruiting in: