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Chronic Lymphocytic LeukemiaPhase 2NCT04016805

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

A Phase 2 study testing Ublituximab, Umbralisib and Ibrutinib in people with Chronic Lymphocytic Leukemia, 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 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Ublituximab, Umbralisib and Ibrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesUnited States
Study dates
5 Aug 2019to 22 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months
  • Minimal Residual Disease positive at screening
  • Adequate organ system function as specified in the protocol
  • Ability to follow protocol procedures.

Who cannot join

  • Participants receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1.
  • Participants with a known histological transformation
  • Active Hepatitis B or Hepatitis C.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • TG Therapeutics Investigational Trial Site

    Boston, Massachusetts, 02114

  • TG Therapeutics Investigational Trial Site

    Hackensack, New Jersey, 07601

  • TG Therapeutics Investigational Trial Site

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Read the detailed description

This is a Phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.

Being tested
Ublituximab, Umbralisib, Ibrutinib, Venetoclax, Acalabrutinib Oral Capsule
Keywords
umbralisib, ublituximab, venetoclax, ibrutinib, CLL, acalabrutinib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • UblituximabDrug

    Also called TG-1101

    • recombinant chimeric anti-CD20 monoclonal antibody
    • administered as an IV infusion

  • UmbralisibDrug

    Also called TGR-1202

    • Phosphoinositide-3-kinase (PI3K) delta inhibitor
    • Tablet form, to taken orally on a daily basis

  • IbrutinibDrug

    Also called Imbruvica

    • Bruton Tyrosine Kinase (BTK) inhibitor
    • Tablet form, to taken orally on a daily basis

  • VenetoclaxDrug

    Also called Venclexta

    • BCL-2 inhibitor
    • Tablet form, to be taken orally

  • Acalabrutinib Oral CapsuleDrug

    Also called Calquence

    Kinase inhibitor, capsule form, to be taken orally

Study groups in NCT04016805
Study groupRoleWhat they receive
ublituximab + umbralisib + ibrutinibExperimentalParticipants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; ibrutinib oral tablet daily (1 Cycle = 28 days).
Receives: Drug: Ublituximab; Drug: Umbralisib; Drug: Ibrutinib
ublituximab + umbralisib + venetoclaxExperimentalParticipants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; venetoclax oral tablet daily (1 Cycle = 28 days).
Receives: Drug: Ublituximab; Drug: Umbralisib; Drug: Venetoclax
ublituximab + umbralisib + acalabrutinibExperimentalParticipants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; acalabrutinib oral capsule every 12 hours (1 Cycle = 28 days).
Receives: Drug: Ublituximab; Drug: Umbralisib; Drug: Acalabrutinib Oral Capsule

What is being measured

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

  1. Rate of Undetected Minimal Residual Disease (U-MRD)

    U-MRD rate was defined as the proportion of participants who have undetectable MRD in the peripheral blood as confirmed by central lab.

    Measured: Up to approximately 23 months

Secondary outcomes (2)

  1. Overall Response Rate (ORR)

    ORR was defined as percent of participants who achieve complete response (CR) or partial response (PR). CR was defined as no evidence of new disease, regression of all target nodal masses to normal size < or = 1.5 cm in the longest diameter (LD) and an absolute lymphocyte count (ALC) in peripheral blood < 4*10^9/L. PR was defined as no evidence of new disease, a decrease in peripheral blood ALC by ≥50% from baseline or a decrease to <4 x 10^9/L or a decrease by ≥50% from the baseline in the sum of the products (SPD) of the target nodal lesions or a decrease by ≥50% from baseline in the CLL marrow infiltrate or in B lymphoid, no target, splenic, liver, or non-target disease with worsening that meets the criteria for definitive nodules, peripheral blood counts with ANC >1.5 x 10^9/L or platelet count ≥100 x 10^9/L or hemoglobin ≥110 g/L (11.0 g/dL) without red blood cell transfusions, all without need for exogenous growth factors.

    Measured: Up to approximately 34 months

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is an AE that starts or worsens after receiving study drug.

    Measured: Up to approximately 34 months

Timeline

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

  1. First posted11 Jul 2019
  2. Study start5 Aug 2019
  3. Primary completion22 May 2022
  4. Study completion22 May 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016805
Sponsor's protocol ID
UTX-TGR-208
Status last verified
Jul 2023
First submitted
10 Jul 2019
Last updated
24 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ublituximab, Umbralisib and Ibrutinib in people with Chronic Lymphocytic Leukemia, 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 4 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 24 Jul 2023. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 24 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Undetected Minimal Residual Disease (U-MRD) (time frame: Up to approximately 23 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 NCT04016805.

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 24 Jul 2023.

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