Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) (ULTRA-V)
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| ClinicalTrials.gov Identifier: NCT03801525 |
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Recruitment Status :
Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : January 23, 2023
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Sponsor:
TG Therapeutics, Inc.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
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Brief Summary:
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | Drug: Ublituximab Drug: Umbralisib Drug: Venetoclax | Phase 2 Phase 3 |
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL) |
| Actual Study Start Date : | May 16, 2019 |
| Estimated Primary Completion Date : | January 1, 2025 |
| Estimated Study Completion Date : | March 1, 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Phase 2: Previously Treated CLL (BTK-Not Refractory) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
Drug: Venetoclax
Other Name: Venclexta® |
| Experimental: Phase 2: Previously Treated CLL (BTK-Refractory) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
Drug: Venetoclax
Other Name: Venclexta® |
| Experimental: Phase 2: Treatment Naïve CLL |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
Drug: Venetoclax
Other Name: Venclexta® |
| Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
Drug: Venetoclax
Other Name: Venclexta® |
| Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
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| Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
Drug: Venetoclax
Other Name: Venclexta® |
| Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2) |
Drug: Ublituximab
Other Name: TG-1101 Drug: Umbralisib
Other Names:
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Primary Outcome Measures :
- Phase 2: Complete Response (CR) Rate [ Time Frame: Up to 12 months ]
- Phase 2: Overall Response Rate [ Time Frame: Up to 12 months ]
- Phase 3: Progression-Free Survival [ Time Frame: 60 months ]Progression-Free Survival in subjects treated with U2-V compared with U2
Secondary Outcome Measures :
- Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
- Phase 3: Overall Response Rate [ Time Frame: Up to 12 months ]Objective response in subjects treated with ublituximab + umbralisib + venetoclax
- Rate of Undetectable Minimal Residual Disease (MRD) [ Time Frame: 60 months ]
- Phase 2: Time to Response (TTR) [ Time Frame: Up to 12 months ]
- Phase 2: Duration of Response (DOR) [ Time Frame: 60 months ]
- Phase 3: Complete Response (CR) Rate [ Time Frame: Up to 12 months ]
- Phase 3: Overall Survival (OS) [ Time Frame: 72 months ]
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:
- Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
- 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
- Prior exposure to any PI3K inhibitor or venetoclax
- Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded
- 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): NCT03801525
Locations
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Sponsors and Collaborators
TG Therapeutics, Inc.
| Responsible Party: | TG Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03801525 |
| Other Study ID Numbers: |
U2-VEN-207 |
| First Posted: | January 11, 2019 Key Record Dates |
| Last Update Posted: | January 23, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data for this study will be shared after the last patient visit has been completed. |
| 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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CLL SLL |
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 Venetoclax Antineoplastic Agents |