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Strategic/Business Decision
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This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.
This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: TG-1701 Monotherapy | Experimental | Participants will receive TG-1701 oral daily dose. As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy. |
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| Arm 2: TG-1701 + Ublituximab + Umbralisib | Experimental | Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy. |
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| Arm 3: Long Term Safety Extension - TG-1701 Monotherapy | Experimental | All the ongoing participants from Arm 1 and 2, will be transitioned to TG-1701 monotherapy in long-term extension period, per protocol version 6.0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-1701 | Drug | Oral daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities. | From first dose up to 30 days post last dose (Up to approximately 4.8 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies | Up to approximately 4.8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constantine S. Tam, MD | St. Vincents Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | East Melbourne | Victoria | Australia | |||
| TG Therapeutics Investigational Trial Site |
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| Umbralisib | Drug | Oral Daily Dose |
|
|
| Ublituximab | Biological | IV infusion |
|
|
| Fitzroy |
| Victoria |
| Australia |
| TG Therapeutics Investigational Trial Site | Nedlands | Western Australia | Australia |
| TG Therapeutics Investigational Trial Site | Adelaide | Australia |
| TG Therapeutics Investigational Trial Site | Krakow | 30-510 | Poland |
| TG Therapeutics Investigational Trial Site | Lublin | 20-090 | Poland |
| TG Therapeutics Investigational Trial Site | Warsaw | 02-781 | Poland |
| TG Therapeutics Investigational Trial Site | Wroclaw | 50-367 | Poland |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626319 | umbralisib |
| C000619007 | ublituximab |
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