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Umbralisib for Follicular Lymphoma

Massachusetts General Hospital Cancer Center, Boston, MA
Follicular Lymphoma+6 More ConditionsUmbralisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination therapy as a first line treatment for Follicular Lymphoma or Marginal Zone Lymphoma.

Eligible Conditions
  • Follicular Lymphoma
  • Follicular Lymphoma Grade 2
  • Follicular Lymphoma Grade 1
  • Follicular Lymphoma Grade IIIa
  • Marginal Zone B-Cell Lymphoma
  • Marginal Zone Lymphoma
  • Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

2 Years
Overall Survival Rate
2 years
Complete Response Rate
Overall Response Rate
Progression Free Survival
Safety and Adverse Events: frequency, severity, and timing of adverse events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Oral Azacitidine
1
Venetoclax
2
Mosunetuzumab

Side Effects for

TCZ/TCZ or TCZ/RTX
15%Nasopharyngitis
6%Hypertension
1%Bronchitis
1%Bursitis
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01332994) in the TCZ/TCZ or TCZ/RTX ARM group. Side effects include: Nasopharyngitis with 15%, Hypertension with 6%, Bronchitis with 1%, Bursitis with 1%.

Awards & Highlights

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 Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Umbralisib+Rituximab
1 of 1

Experimental Treatment

41 Total Participants · 1 Treatment Group

Primary Treatment: Umbralisib · No Placebo Group · Phase 2

Umbralisib+RituximabExperimental Group · 2 Interventions: Umbralisib, Rituximab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbralisib
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,782 Previous Clinical Trials
31,225,160 Total Patients Enrolled
TG TherapeuticsUNKNOWN
Jacob D. Soumerai, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have marginal zone lymphoma, you cannot have received any systemic treatment for it before. However, if you have had radiation or surgery for it, you may still be eligible if there is measurable disease outside of the treated area. Any radiation treatment must have been completed at least 2 weeks before starting the study treatment. If you have received H. pylori eradication therapy, that is allowed.
You need treatment because your lymphoma is causing symptoms, organ damage, or compression. You also need treatment if you have low blood cell counts, large tumors, or if your lymphoma is steadily getting worse.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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