Clinical Trials Archives

November 14, 2023

Can Surrogate Markers Speed Up Clinical Trials in CLL?

Both progression free survival (PFS) and measurable (minimal) residual disease (MRD) status were found to strongly correlate with overall survival (OS), suggesting these markers could be safely used as surrogates for OS and thus provide quicker results in clinical trials.

October 26, 2023

CLL Society Commends the FDA on Its Innovative Approach to Balancing Quicker Drug Approval with Assuring Underrepresented Communities Participate in Clinical Trials

CLL Society applauds the FDA for approaching this long standing problem with flexibility that allows patients access to potentially lifesaving medications sooner, while still requiring drugs be appropriately studied in all populations that might benefit.

October 18, 2023

The Usefulness of Surrogate Markers in Clinical Trials for Chronic Lymphocytic Leukemia (CLL) – ICML 2023

Overall response rate (ORR) is a robust surrogate marker for progression-free survival (PFS), especially when chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) is treated with a Bruton tyrosine kinase inhibitor (BTKi) such as ibrutinib, acalabrutinib or zanubrutinib, but is not well correlated with overall survival (OS).

June 2, 2023

Dr. O’Brien on Equipoise in Trial Design for CLL / SLL

Dr. Susan O’Brien eloquently addressed the issue of equipoise in clinical trials for CLL / SLL a full 10 years ago.

May 2, 2023

ASH 2022: Dr. Mazyar Shadman on Enitociclib, a CDK9 Inhibitor, for Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

We discuss enitociclib, an experimental CDK9 inhibitor in development for treating NHL and CLL.

April 26, 2023

Observational Study of Cardiac Arrhythmia in Subjects Treated With BTK Inhibitors

BTK inhibitors have revolutionized the care of CLL / SLL patients and profoundly improved outcomes

February 15, 2023

ASH 2022: Dr. James Blachly Discusses Results from a Phase 1/2 Dose Escalation and Expansion Study Evaluating MS-533, a Novel and Selective Protein Kinase C-Beta Inhibitor in Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

MS-553, a protein kinase C-beta (PKCß) inhibitor, is an exciting new agent in a yet-to-be-approved class of drugs that target an area of the B-cell receptor pathway independent of Bruton tyrosine kinase (BTK) and phospholipase C gamma 2 (PLCy2) mutations which confer resistance to BTK inhibitors.

February 6, 2023

ASH 2022: Dr. Parag Jasani on NVG-111, a ROR1 Targeting Bispecific T Cell Engager, for Chronic Lymphocytic Leukemia (CLL)

Our own Dr. Brian Koffman interviewed Dr. Parag Jasani, a consultant hematologist with Royal Free London NHS Trust and University College London Hospitals. They discussed a first-in-human study of an experimental drug, NVG-111, a bispecific T cell engager. NVG-111 binds to ROR1 on cancer cells and CD3 on T

January 6, 2023

ASH 2022: Dr. Christine Ryan on Triple Combination Acalabrutinib, Venetoclax, and Obinutuzumab for High-Risk Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL / SLL)

In this ongoing trial, the triple combination therapy with acalabrutinib, venetoclax, and obinutuzumab is highly active and has thus far produced durable remissions as a frontline treatment in patients with TP53-aberrant chronic lymphocytic leukemia (CLL), which was generally well tolerated with a low 2.9% incidence of atrial fibrillation with

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Clinical Trials

Can Surrogate Markers Speed Up Clinical Trials in CLL?

CLL Society Commends the FDA on Its Innovative Approach to Balancing Quicker Drug Approval with Assuring Underrepresented Communities Participate in Clinical Trials

The Usefulness of Surrogate Markers in Clinical Trials for Chronic Lymphocytic Leukemia (CLL) – ICML 2023

Dr. O’Brien on Equipoise in Trial Design for CLL / SLL

ASH 2022: Dr. Mazyar Shadman on Enitociclib, a CDK9 Inhibitor, for Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Observational Study of Cardiac Arrhythmia in Subjects Treated With BTK Inhibitors

ASH 2022: Dr. James Blachly Discusses Results from a Phase 1/2 Dose Escalation and Expansion Study Evaluating MS-533, a Novel and Selective Protein Kinase C-Beta Inhibitor in Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

ASH 2022: Dr. Parag Jasani on NVG-111, a ROR1 Targeting Bispecific T Cell Engager, for Chronic Lymphocytic Leukemia (CLL)

ASH 2022: Dr. Christine Ryan on Triple Combination Acalabrutinib, Venetoclax, and Obinutuzumab for High-Risk Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL / SLL)

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