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
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| ClinicalTrials.gov Identifier: NCT04016805 |
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Recruitment Status :
Terminated
(Strategic/Business decision)
First Posted : July 11, 2019
Last Update Posted : January 26, 2023
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Sponsor:
TG Therapeutics, Inc.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
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Brief Summary:
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in subjects with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia | Drug: Ublituximab Drug: Umbralisib Drug: Ibrutinib Drug: Venetoclax Drug: Acalabrutinib Oral Capsule | Phase 2 |
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 subjects with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 84 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 5, 2019 |
| Actual Primary Completion Date : | May 22, 2022 |
| Actual Study Completion Date : | May 22, 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: ublituximab + umbralisib + ibrutinib
ublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily ibrutinib: dose tolerated by subject; to be administered daily |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Name: TGR-1202 Drug: Ibrutinib
Other Name: Imbruvica |
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Experimental: ublituximab + umbralisib + venetoclax
ublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily venetoclax: dose tolerated by subject; to be administered daily |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Name: TGR-1202 Drug: Venetoclax
Other Name: Venclexta |
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Experimental: ublituximab + umbralisib + acalabrutinib
ublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily acalabrutinib: previously tolerated dose; to be administered every 12 hours |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Name: TGR-1202 Drug: Acalabrutinib Oral Capsule Kinase inhibitor, capsule form, to be taken orally
Other Name: Calquence |
Primary Outcome Measures :
- Rate of minimal residual disease negativity [ Time Frame: 24 months ]Assess the rate of undetectable minimal residual disease (U-MRD)
Secondary Outcome Measures :
- Overall Response Rate [ Time Frame: 24 months ]Objective response in subjects treated on study
- Adverse Events that are Related to Treatment [ Time Frame: 12 months ]Number of Participants With Treatment-Related Adverse Events
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects 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.
Exclusion Criteria:
- Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1.
- Subjects with a known histological transformation
- Active Hepatitis B or Hepatitis C.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016805
Locations
| United States, Massachusetts | |
| TG Therapeutics Investigational Trial Site | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New Jersey | |
| TG Therapeutics Investigational Trial Site | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| TG Therapeutics Investigational Trial Site | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
TG Therapeutics, Inc.
| Responsible Party: | TG Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04016805 |
| Other Study ID Numbers: |
UTX-TGR-208 |
| First Posted: | July 11, 2019 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by TG Therapeutics, Inc.:
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umbralisib ublituximab venetoclax |
ibrutinib CLL acalabrutinib |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes Venetoclax Acalabrutinib Antineoplastic Agents |