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Monoclonal Antibodies

Umbralisib for Lymphoma

Phase 2
Waitlist Available
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 35 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs may help treat follicular lymphoma and small lymphocytic lymphoma.

Eligible Conditions
  • Lymphoma
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 35 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Number of Participants With Treatment-emergent Adverse Events (TEAE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Progression-Free Survival (PFS)

Side effects data

From 2022 Phase 2 trial • 21 Patients • NCT03364231
50%
Diarrhoea
50%
Nausea
38%
Dizziness
25%
Asthenia
25%
Anaemia
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
Fatigue
25%
Oedema peripheral
25%
Hypertension
25%
Oropharyngeal pain
25%
Decreased apetite
25%
Abdominal distension
25%
Abdominal pain
25%
Back pain
13%
Feeling abnormal
13%
Dysgeusia
13%
Colitis
13%
Hypercholesterolaemia
13%
Migraine
13%
Hypermagnesaemia
13%
Hypokalaemia
13%
Hyperglycemia
13%
Dyspneoa
13%
Tachycardia
13%
Vomiting
13%
Contusion
13%
Pyrexia
13%
Throat irritation
13%
Blood alkaline phosphatase increased
13%
Seasonal allergy
13%
Gout
13%
Hypernatraemia
13%
Urinary incontinence
13%
Upper airway cough syndrome
13%
Accidental overdose
13%
Blood creatinine increased
13%
Rash macular
13%
Headache
13%
Fall
13%
Hyperuricemia
13%
Foot fracture
13%
Intervertebral disc degeneration
13%
Annular elastolytic giant cell granuloma
13%
Cough
13%
Early satiety
13%
Hypomagnesaemia
13%
Arthralgia
13%
Pruritis
13%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
MZL: Umbralisib
WM: Umbralisib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ublituximab + UmbralisibExperimental Treatment2 Interventions
Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~2090
Umbralisib
2015
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,603 Total Patients Enrolled
12 Trials studying Lymphoma
1,070 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
2019. "Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03828448.
~6 spots leftby Apr 2025
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