Umbralisib for Chronic Lymphocytic Leukemia (CLL)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
TG Therapeutics Investigational Trial Site, Boston, MA
Chronic Lymphocytic Leukemia (CLL)+3 More
Umbralisib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the addition of two drugs to current treatments may help patients with chronic lymphocytic leukemia.

See full description

Eligible Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Chronic Lymphocytic Leukemia (CLL)

Study Objectives

This trial is evaluating whether Umbralisib will improve 1 primary outcome and 2 secondary outcomes in patients with Chronic Lymphocytic Leukemia (CLL). Measurement will happen over the course of 12 months.

12 months
Adverse Events that are Related to Treatment
24 months
Overall Response Rate
Rate of minimal residual disease negativity

Trial Safety

Safety Progress

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

Other trials for Chronic Lymphocytic Leukemia (CLL)

Trial Design

3 Treatment Groups

ublituximab + umbralisib + acalabrutinib
1 of 3
ublituximab + umbralisib + venetoclax
1 of 3
ublituximab + umbralisib + ibrutinib
1 of 3
Experimental Treatment

This trial requires 84 total participants across 3 different treatment groups

This trial involves 3 different treatments. Umbralisib is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

ublituximab + umbralisib + acalabrutinibublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily acalabrutinib: previously tolerated dose; to be administered every 12 hours
ublituximab + umbralisib + venetoclaxublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily venetoclax: dose tolerated by subject; to be administered daily
ublituximab + umbralisib + ibrutinibublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily ibrutinib: dose tolerated by subject; to be administered daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
Not yet FDA approved
Ibrutinib
FDA approved
Venetoclax
FDA approved
Umbralisib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

TG Therapeutics Investigational Trial Site - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Minimal Residual Disease positive at screening
Adequate organ system function as specified in the protocol
Ability to follow protocol procedures.
Subjects with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months

Patient Q&A Section

Can leukemia be cured?

"The cure of leukemia is a long, sometimes frustrating and frustrating process, and can be a boon for the patient's mind and for the medical community. However, many of the issues related to cure are less clear-cut than we might first believe. If we are to move to the field of cure we should learn to differentiate between the cure of "the disease" and the cure of a patient. This article discusses the different levels of cure as it applies to the many patients with leukemia." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"Symptoms of leukemia include weight loss, tiredness, malaise, anemia, and fatigue. Fever and low white blood cell count also occur. Some symptoms may be indicative of other conditions, such as infections with the Epstein-Barr virus." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"Leukemia is cancer of the bone marrow that most often occurs in adults with the typical symptoms of fever, weight loss, and easy bruising and bleeding. It is now well understood that leukemia results from the abnormal proliferation of blood-forming or leukemic cells, most commonly precursor T lymphocytes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"Many patients with leukemia receive treatments for their cancer. There are no established guidelines for how these treatments should be administered. Treatment may involve surgery or chemi-therapy to control the cancer and to help the patient or their family manage side effects of these treatments.\n\nThere are many factors that determine whether the cancer progresses. Some factors are: \n\nThe underlying genetic cause of the cancer is the most important determinant of how the cancer evolves and how it responds to therapy. There is currently no known cure for leukemia. There are some targeted therapies that have been shown to improve the outcomes for patients." - Anonymous Online Contributor

Unverified Answer

What causes leukemia?

"There is no single factor that accounts completely for the development of leukemia. Rather, factors that are present in leukemia are often found in combination. This suggests that several factors must be involved in the development of leukemia.\n" - Anonymous Online Contributor

Unverified Answer

How many people get leukemia a year in the United States?

"In 2002, around 22,000 people in the US had leukemia of all types. This is around 1.2% of the US adult population. Although childhood leukemias made up 57% of all leukemias, they represent only 4% of the US adult leukemias. The average age at diagnosis is 67 years for both children and adult leukemias. The overall 5-year survival rate is 73% in children with leukemia and 76% in adults (1997). In adults, the 5-year overall survival rate is 91% for acute leukemia, 59% for chronic lymphocytic leukemia, and 67% for chronic myeloid leukemia." - Anonymous Online Contributor

Unverified Answer

Has umbralisib proven to be more effective than a placebo?

"The data demonstrates the high efficacy of daily dosage of umbralisib compared to placebo with favorable clinical outcome. Due to the short period on treatment, it was not able to determine the clinical efficacy of the therapy beyond a short time. Findings from a recent study support further clinical evaluation and optimization of the new drug umbralisib for the treatment of leukemia"

"Dendrophilia pudens\n\nDendrophilia pudens is a moth of the family Gelechiidae. It was described by Walsingham in 1909. It is found in Mexico (Tabasco)." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia?

"The latest information on leukemia was found on an NIH site where scientists, in order to study different blood diseases, have collaborated to study leukemia and work on new treatments for cancer and leukemia. It is necessary that our research should be done in research labs where we find new medicines not only in the field of research that we have already mentioned in the beginning of this article, but to find a way to treat the disease. To discover drugs that work in vivo should be the ultimate goal in science, because it would help save lots of dead leukemia patients, in addition to the current research that we have done here in this article will help in finding medicines for treatment of leukemia for future generations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of umbralisib?

"The common side effects of umbralisib are headache (40%), diarrhea (39%), fatigue (36%), nausea (26%), and peripheral edema (20%). Some side effects, such as fatigue, headache, and dizziness, occur in high incidence and most are Grade 1 or Grade 2 (defined as Grade 1 when severity grade rating ≤ 2 and Grade 2 when severity grade rating > 2 and > 5% when occurring in ≥10% of patients). Most severe side effects are Grade 3 and all occur in ≤10% of patients (Grade 3 in ≤ 2% and Grade 3 in 0.1% when occurring in ≥10% of patients)." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia?

"Trial eligibility is a complex issue, based on our analysis on existing studies. Physicians should consider their patients individually, because they have specific characteristics affecting clinical trial eligibility." - Anonymous Online Contributor

Unverified Answer

Is umbralisib typically used in combination with any other treatments?

"These data raise concern of the possible increased toxicity and mortality associated with the use of umbralisib in combination with other treatments. Clinicians should carefully monitor such patients during treatment." - Anonymous Online Contributor

Unverified Answer

Does umbralisib improve quality of life for those with leukemia?

"Umbralisib improved quality of life in children with acute leukemia, including improvement in the number of days without neutropenia. Umbralisib was well-tolerated, especially with dosing schedules of 2 or 3 days per week." - 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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