- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647971
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35805
- TG Therapeutics Investigational Trial Site
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- TG Therapeutics Investigational Trial Site
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Georgia
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Athens, Georgia, United States, 30607
- TG Therapeutics Investigational Trial Site
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Macon, Georgia, United States, 31201
- TG Therapeutics Investigational Trial Site
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Maryland
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Bethesda, Maryland, United States, 20817
- TG Therapeutics Investigational Trial Site
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New Jersey
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Morristown, New Jersey, United States, 07962
- TG Therapeutics Investigational Trial Site
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New York
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New York, New York, United States, 10022
- TG Therapeutics Investigational Trial Site
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Tennessee
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Memphis, Tennessee, United States, 38120
- TG Therapeutics Investigational Trial Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Relapsed or Refractory B-cell Lymphoma
- Measurable or Evaluable Disease
- Previously treated with at least one line of rituximab or a rituximab based therapy
- Patients ineligible for high dose or combination chemotherapy + stem cell transplant
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology
Exclusion Criteria:
- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
- Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
- History of severe hypersensitivity or anaphylaxis to prior rituximab
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ublituximab
Phase I: 4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 & 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply. |
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Subjects will be followed for 4 weeks
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Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
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Subjects will be followed for 4 weeks
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Maximum Tolerated Dose acceptable for participants
Time Frame: Subjects will be followed for 4 weeks
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The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
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Subjects will be followed for 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: Participants will be evaluated approximately every 8 - 12 weeks
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Efficacy will include overall response rate, duration of response and progression-free survival
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Participants will be evaluated approximately every 8 - 12 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic profile including Peak Plasma Concentration (Cmax)" or "Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC)
Time Frame: Up to 6 months
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Up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: TG Therapeutics Clinical Trials, TG Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
Other Study ID Numbers
- TGTX 1101-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Ublituximab
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TG Therapeutics, Inc.CompletedChronic Lymphocytic LeukemiaUnited States, Israel
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Johns Hopkins UniversityCompletedNeuromyelitis Optica | Neuromyelitis Optica Spectrum DisorderUnited States
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TG Therapeutics, Inc.CompletedMultiple SclerosisUnited States
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TG Therapeutics, Inc.TerminatedStudy to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular LymphomaFollicular Lymphoma | Small Lymphocytic LymphomaUnited States