Follicular Lymphoma Clinical Trial
Official title:
A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
Verified date | June 2024 |
Source | TG Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy - Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018) - Treatment Status: 1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics) 2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT 3. CLL subjects: relapsed to or refractory after at least two prior standard therapies - Measurable disease defined as: 1. NHL (including SLL): at least 1 measurable disease lesion > 1.5 centimeters (cm) 2. CLL: at least 1 measurable disease lesion Exclusion Criteria: - Prior therapy with any agent blocking the CD47/SIRPa pathway or any previous CD19 targeting therapy, - Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1. - Prior autologous stem cell transplant (SCT) within 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | TG Therapeutics Investigational Trial Site | Chattanooga | Tennessee |
United States | TG Therapeutics Investigational Trial Site | Fayetteville | Arkansas |
United States | TG Therapeutics Investigational Trial Site | Hackensack | New Jersey |
United States | TG Therapeutics Investigational Trial Site | Houston | Texas |
United States | TG Therapeutics Investigational Trial Site | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
TG Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RP2D | To determine the recommended Phase 2 dose (RP2D) | Up to 24 months | |
Secondary | Overall Response Rate | To evaluate the overall response rate (ORR) of TG-1801 | Up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03078855 -
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
|
Phase 3 | |
Active, not recruiting |
NCT03245021 -
Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A
|
Phase 1 | |
Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT02213263 -
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
|
Phase 3 | |
Completed |
NCT01691898 -
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
|
Phase 1/Phase 2 | |
Terminated |
NCT03585725 -
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
|
Early Phase 1 | |
Terminated |
NCT00772668 -
Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL
|
N/A | |
Recruiting |
NCT02892695 -
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Terminated |
NCT02204982 -
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
|
Phase 3 | |
Terminated |
NCT00850499 -
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
|
Phase 2 | |
Completed |
NCT02536664 -
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
|
||
Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
Terminated |
NCT00136591 -
A Phase 2 Study of Velcadeā¢ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
|
Phase 2 | |
Not yet recruiting |
NCT06068881 -
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation
|
Phase 2 | |
Completed |
NCT04034056 -
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
|