Opening Trials & Status Updates Archives

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

November 18, 2022

Obinutuzumab/Acalabrutinib/Venetoclax Combo Misses the Mark for MRD in Advanced Chronic Lymphocytic Leukemia (CLL)

The combination of obinutuzumab (Gazyva), acalabrutinib (Calquence), and venetoclax (Venclexta) failed to meet the pre-specified rate of undetectable measurable or minimal residual disease (uMRD) following optimal debulking with bendamustine in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

October 12, 2022

ASH 2021: MAJIC – A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

In summary, the results of MAJIC will help to inform the selection of time-limited doublet therapy approaches for patients with CLL/SLL and help define the duration of venetoclax in combination with either acalabrutinib or obinutuzumab.

September 22, 2022

ASH 2021: Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Dr. Javier Pinilla Ibarz and colleagues presented this research at the American Society for Hematology annual meeting, which was held in December 2021 (ASH 2021).

July 13, 2022

ASH 2021: Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (R/R CLL/SLL)

Dr. Matthew Davids and colleagues presented this research at the American Society for Hematology annual meeting held in December 2021 (ASH 2021).

June 2, 2022

ASH 2021: Dr. Jennifer Woyach on a Clinical Trial in Progress with Combination Ibrutinib, Venetoclax, and Obinutuzumab

Discussion of a phase 3 clinical trial in progress, investigating the efficacy of the triple combination of ibrutinib plus venetoclax and obinutuzumab with response-dependent discontinuation.

February 24, 2022

ASH 2021: BRUIN CLL-321: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Trial in Progress)

Dr. Jeff Sharman and colleagues presented this research at the American Society for Hematology annual meeting held December 2021 (ASH 2021).

February 4, 2022

FDA Places Partial Clinical Hold on Studies Featuring Umbralisib and Ublituximab in CLL and Non-Hodgkin Lymphoma

The combination of umbralisib plus ublituximab, often abbreviated to U2, has promising activity in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) as shown in this ASH 2021 abstract:

January 21, 2022

Idelalisib for Relapsed Follicular Lymphoma (FL) and Small Lymphocytic Leukemia (SLL) Voluntarily Withdrawn from US Market

Idelalisib (Zydelig) was once known as CAL-101 and was the most exciting new oral therapy in the CLL world, the shining morning star in the dawn of a new era of treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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Opening Trials & Status Updates

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)

Obinutuzumab/Acalabrutinib/Venetoclax Combo Misses the Mark for MRD in Advanced Chronic Lymphocytic Leukemia (CLL)

ASH 2021: MAJIC – A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

ASH 2021: Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

ASH 2021: Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (R/R CLL/SLL)

ASH 2021: Dr. Jennifer Woyach on a Clinical Trial in Progress with Combination Ibrutinib, Venetoclax, and Obinutuzumab

ASH 2021: BRUIN CLL-321: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Trial in Progress)

FDA Places Partial Clinical Hold on Studies Featuring Umbralisib and Ublituximab in CLL and Non-Hodgkin Lymphoma

Idelalisib for Relapsed Follicular Lymphoma (FL) and Small Lymphocytic Leukemia (SLL) Voluntarily Withdrawn from US Market

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