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Monoclonal Antibody
Umbralisib + Rituximab for Lymphoma
Phase 2
Waitlist Available
Led By Jacob D. Soumerai, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2
creatinine within normal institutional limits OR creatinine clearance ≥30 mL/min for participants with creatinine levels above institutional normal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy as a first line treatment for Follicular Lymphoma or Marginal Zone Lymphoma.
Who is the study for?
Adults diagnosed with grade 1-3A follicular lymphoma or marginal zone lymphoma who need treatment and haven't had systemic therapy for it. They should have measurable disease, be in good physical condition (ECOG ≤2), and have normal organ function. Women of childbearing age must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Umbralisib combined with Rituximab as a first-line treatment for patients with Follicular Lymphoma or Marginal Zone Lymphoma. It aims to evaluate the effectiveness and safety of this combination therapy in individuals who are newly diagnosed.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from compounds related to umbralisib or rituximab, liver issues, infections, digestive problems like irritable bowel syndrome, heart complications such as arrhythmias or heart failure, and blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidney function, measured by creatinine or its clearance, is within the normal range.
Select...
I have a tumor that can be measured and is larger than the specified size.
Select...
My lymphoma is confirmed as follicular grade 1-3A or marginal zone.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Secondary outcome measures
Overall Response Rate
Overall Survival Rate
Progression Free Survival
+1 moreSide effects data
From 2022 Phase 2 trial • 21 Patients • NCT0336423150%
Diarrhoea
50%
Nausea
38%
Dizziness
25%
Anaemia
25%
Asthenia
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: Umbralisib+RituximabExperimental Treatment2 Interventions
A treatment cycle is defined as 28 consecutive days.
Umbralisib will be administered at 800 mg by mouth once daily on days 1-28 of cycles 1-24.
Rituximab will be administered at 375 mg/m2 by intravenous infusion on Cycle 1 Day 1 and may be administered at 375 mg/m2 by intravenous infusion or at 1400 mg by subcutaneous injection on days 8, 15, 22 of cycle 1, day 1 of cycles 2 to 6, then every 8 weeks starting on day 1 of cycle 7 until completion of 24 cycles of umbralisib (i.e. every other cycle for 18 cycles or 9 doses, for a total of 15 doses of rituximab), or until progression or intolerance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbralisib
FDA approved
Rituximab
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,314 Total Patients Enrolled
TG TherapeuticsUNKNOWN
Jacob D. Soumerai, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications similar to umbralisib or rituximab.I have had a stem cell transplant from a donor.My blood cell counts are within a healthy range, not due to lymphoma.I can take care of myself but might not be able to do heavy physical work.I am cautious with medications that can affect my heart's rhythm.I need immediate treatment to reduce my cancer cells.My marginal zone lymphoma has not improved despite treating my hepatitis C.I have an inflammatory bowel condition like Crohn's disease or ulcerative colitis.My kidney function, measured by creatinine or its clearance, is within the normal range.My lymphoma has changed into a large cell type.I have a condition that prevents my body from absorbing nutrients properly.I have follicular lymphoma and haven't received systemic therapy for it, but I may have had radiation to one disease site.I have a tumor that can be measured and is larger than the specified size.I am not pregnant or breastfeeding.I am not pregnant or agree to use birth control during and after the study.I haven't had cancer, except for certain skin, cervix, bladder, or prostate cancers, in the last 3 years.I haven't had systemic therapy for another cancer in the last 2 years.I have severe heart failure symptoms or a history of it.I haven't had major heart or blood vessel problems in the last 6 months.My lymphoma is confirmed as follicular grade 1-3A or marginal zone.I have a history of liver disease or damage.I have marginal zone lymphoma and haven't had systemic therapy for it, but I may have had radiation or surgery.My organs are functioning well.My stomach lymphoma did not improve after treating H. pylori.I do not have any ongoing serious infections.I haven't taken high-dose steroids by mouth in the last week.My lymphoma has spread to my brain or spinal cord.I need treatment because my symptoms are getting worse or my cancer is affecting my organs.I do not have active hepatitis B, C, CMV, or HIV.I am older than 18 years.I have irritable bowel syndrome with more than 3 loose stools daily.You have a mental health condition or personal circumstances that would make it difficult for you to follow the study rules.I do not have serious heart problems like uncontrolled heart rhythm issues or recent heart attacks.
Research Study Groups:
This trial has the following groups:- Group 1: Umbralisib+Rituximab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still able to sign up for this experiment?
"That is correct. The clinicaltrials.gov website shows that this trial, which was originally posted on September 1st 2019, is still recruiting patients. They are looking for 41 individuals total, from 2 different sites."
Answered by AI
Has Umbralisib received any governmental regulation for public consumption?
"While there is some evidence that Umbralisib is safe for human use, Phase 2 trials mean that there is currently no data backing its efficacy."
Answered by AI
What are the conditions that Umbralisib has been shown to be most effective against?
"Umbralisib is an effective treatment for relapsed marginal zone lymphoma, diffuse large b-cell lymphoma (dlbcl), and other types of b-lymphocytes."
Answered by AI
How many total individuals are included in this clinical trial?
"Yes, this is an ongoing trial that was posted on September 1st, 2019 and last updated on August 31st, 2020. The study is looking for 41 individuals at 2 different research facilities."
Answered by AI
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