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Chronic Lymphocytic LeukemiaPhase 1/2NCT03379051

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

A Phase 1/2 study testing Venetoclax, Umbralisib and Ublituximab in people with Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, run by TG Therapeutics, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venetoclax, Umbralisib and Ublituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
3 sitesUnited States
Study dates
27 Mar 2018to 16 Jun 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma
  • Refractory to or relapsed after at least 1 prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Who cannot join

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • TG Therapeutics Investigational Trial Site

    Chicago, Illinois, 60611

  • TG Therapeutics Investigational Trial Site

    Cleveland, Ohio, 44195

  • TG Therapeutics Investigational Trial Site

    Rochester, New York, 14642

Other trials in United States

About this study

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Being tested
Venetoclax, Umbralisib, Ublituximab, Lenalidomide
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called Venclexta

    BCL-2 Inhibitor

  • UmbralisibDrug

    Also called TGR-1202

    PI3K-Delta Inhibitor

  • UblituximabBiological

    Also called TG-1101

    Glycoengineered Anti-CD20 mAb

  • LenalidomideDrug

    Also called Revlimid

    Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties

Study groups in NCT03379051
Study groupRoleWhat they receive
Ublituximab + Umbralisib + VenetoclaxExperimentalUblituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Receives: Drug: Venetoclax; Drug: Umbralisib; Biological: Ublituximab
Ublituximab + Umbralisib + LenalidomideExperimentalUblituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Receives: Drug: Umbralisib; Biological: Ublituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine Acceptable Adverse Events That Are Related to Treatment

    Measured: 12 months

Secondary outcomes (2)

  1. Overall Response and Complete Remission Rate

    Measured: 12 months

  2. Minimum Residual Disease (MRD)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2017
  2. Study start27 Mar 2018
  3. Primary completion26 May 2022
  4. Study completion16 Jun 2022

Why it stopped: Strategic/Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03379051
Sponsor's protocol ID
U2-VEN-109
Status last verified
Aug 2022
First submitted
14 Dec 2017
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693.

    PubMed 37871300

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Venetoclax, Umbralisib and Ublituximab in people with Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, run by TG Therapeutics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic/Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine Acceptable Adverse Events That Are Related to Treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03379051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.

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