Opening Trials & Status Updates

Opening Trials & Status Updates

Clinical Trials can greatly broaden the potential for effective treatment for your CLL. When trials open, close, have important amendments, holds, or are affected by other regulatory news, we will report on it here.

Action Items for Opening Trials & Status Updates

Watch this page.

This is where we report the latest news concerning clinical trials.

Study up.

Knowing common inclusion and exclusion criteria for a future clinical trial can be helpful when planning CLL/SLL treatments.

Be ready.

Timing can be important. Clinical trials open and close and sometimes one might need to move quickly if the perfect trial is open.

Be aware and don’t jump to conclusions.

Trials may be closed or paused for many reasons completely unrelated to safety or efficacy.

Watch this page.

This is where we report the latest news concerning clinical trials.

Study up.

Knowing common inclusion and exclusion criteria for a future clinical trial can be helpful when planning CLL/SLL treatments.

Be ready.

Timing can be important. Clinical trials open and close and sometimes one might need to move quickly if the perfect trial is open.

Be aware and don’t jump to conclusions.

Trials may be closed or paused for many reasons completely unrelated to safety or efficacy.

FEATURE

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

The FDA has placed a partial hold on clinical trials using umbralisib plus ublituximab, often abbreviated to U2, in CLL and other lymphomas due to a possible increased mortality risk.

The combination of umbralisib plus ublituximab has promising activity in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) as shown in this ASH 2021 abstract: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study.

That study showed that U2 significantly prolonged progression-free survival (PFS) compared to Obinutuzumab plus Chlorambucil (O+Chl) (median 31.9 months vs 17.9 months), but PFS is not the whole story. Read more.

ADDITIONAL READING