NCT01647971|CompletedPhase 1DMC

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

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

TGTX 1101-101

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2012

StartedJul 2012

CompletionMay 2015

Brief Summary

The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

July 17, 2012

Completed

2 days until next milestone

Study Start

First participant enrolled

July 19, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

2.8 years

First QC Date

July 17, 2012

Last Update Submit

November 16, 2022

Conditions

Non-Hodgkins Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia Marginal Zone Lymphoma Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Primary Central Nervous System Lymphoma

Keywords

LymphomaRituxanRelapsedRefractory

Outcome Measures

Primary Outcomes (2)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Subjects will be followed for 4 weeks
Maximum Tolerated Dose acceptable for participants
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Subjects will be followed for 4 weeks

Secondary Outcomes (1)

Efficacy
Participants will be evaluated approximately every 8 - 12 weeks

Other Outcomes (1)

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)
Up to 6 months

Study Arms (1)

ublituximab

EXPERIMENTAL

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.

Drug: Ublituximab

Interventions

UblituximabDRUG

Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

ublituximab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.