Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

Next Previous
Trial Profile

Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 May 2024

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Ublituximab (Primary) ; Umbralisib (Primary) ; Chlorambucil; Obinutuzumab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITY-CLL
  • Sponsors TG Therapeutics Inc

Most Recent Events

  • 09 May 2023 This trial has been discontinued in Poland, according to European Clinical Trials Database record.
  • 15 Apr 2022 According to a TG Therapeutics media release, the April 22, 2022, ODAC meeting will be canceled, as company decided to withdraw the pending BLA/sNDA for U2 to treat CLL/SLL.
  • 15 Apr 2022 According to a TG Therapeutics media release, the company has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and UKONIQ (umbralisib) for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. The decision to withdraw was based on recently updated overall survival data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top