TG-1801 for Leukemia, Lymphocytic, Chronic, B-Cell

1
Effectiveness
1
Safety
TG Therapeutics Investigational Trial Site, Fayetteville, AR
Leukemia, Lymphocytic, Chronic, B-Cell+13 More
TG-1801 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Chronic, B-Cell

Study Summary

Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

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Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, B-Cell
  • Lymphoma
  • Leukemia, Lymphoid
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Indolent Lymphoma
  • MCL
  • Chronic Lymphocytic Leukemia (CLL)
  • Follicular Lymphoma ( FL)
  • Richter's Transformation
  • Aggressive Lymphoma
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma (MZL)
  • Mediastinal Large B Cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TG-1801 will improve 1 primary outcome and 1 secondary outcome in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of 24 months.

24 months
Overall Response Rate
RP2D

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
TG-1801 + Ublituximab

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. TG-1801 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

TG-1801 + UblituximabTG-1801 in combination with ublituximab
TG-1801
Biological
TG-1801 Single Agent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
Not yet 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 - Fayetteville, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Leukemia, Lymphocytic, Chronic, B-Cell or one of the other 13 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
CLL: at least 1 measurable disease lesion
B-cell non-Hodgkin lymphoma (NHL) including RT and transformed FL, that warrants systemic therapy
Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by iwCLL (Hallek 2018)
NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
RT subjects: must have relapsed after or be refractory to at least two prior line of therapy for CLL/SLL or RT
CLL subjects: relapsed to or refractory after at least two prior standard therapies
NHL (including SLL): at least 1 measurable disease lesion > 1.5 cm

Patient Q&A Section

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

What is leukemia, lymphocytic, chronic, b-cell?

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Leukemia, lymphocytic, chronic, b-cell is a deadly, often chronic, and debilitating disease. The disease usually affects young adults, especially those at a young age, and in the US, it is estimated that about 12,000 new cases of leukemia occur each year.

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

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Leukemia, lymphocytic, chronic, b-cell was found to be highly resistant to conventional modes of therapy. However, in some cases, b-cell acute lymphoblastic, chronic lymphocytic, and non-Hodgkin's-type can be effectively treated with highly specific agents, with one example being azacitidine, which has earned U.S. Food and Drug Administration approval in 2001. With this treatment, durable remissions and complete responses can be accomplished. Azacitidine has proven to be a very effective and safe therapy for acute B-cell chronic lymphocytic, non-Hodgkin disease.

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How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

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Based on these numbers, leukemia, lymphocytic, chronic, b-cell and non-Hodgkin lymphoma (NHL) represent between 0.1% and 1% of all cancer cases in the US each year. These values fluctuate. For instance, in 1999 leukemias, lymphocytic or chronic, b-cell represented about 10% of all cancer cases, but in that same year non-Hodgkin lymphomas represented about 30%, while in 1998 the reverse could be true: non-Hodgkin lymphomas represented about 30% of all cancer cases but leukemias, lymphocytic or chronic, b-cell represented only 4% of all cancer cases in that year.

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What are the signs of leukemia, lymphocytic, chronic, b-cell?

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Signs suggestive of leukemia, lymphocytic, chronic, b-cell involve all three forms of the leukemia. These include persistent fevers, persistent cough, weight loss, and easy bruising or bleeding.\n

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What are common treatments for leukemia, lymphocytic, chronic, b-cell?

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The treatment of cancer with radiation may lead to temporary or permanent changes in the functioning of the body. The use of oral chemotherapy agents and anti-neoplastic agents and their side effects and interactions with other medications may diminish normal functioning of the body.

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What causes leukemia, lymphocytic, chronic, b-cell?

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Inherited and acquired genetic abnormalities are thought to create the same disease phenotype. Those who are of European background have an increased risk for developing leukemia, whereas those of African, Hispanic, and Asian background have an increased risk of developing lymphocytic chronic leukemias. Those who have been exposed to a chemical or radiation to the body or an infectious agent in childhood, young adult life, and adolescence may be at increased risk of developing this disorder.

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What is tg-1801?

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The identification of this new T-cell leukemia/lymphoma-associated gene as the cellular target of the immunotoxin diphtheria toxin suggests novel strategies in the treatment of tumors expressing this gene, as well as possible therapeutic applications in treating leukocytic immunodeficiency states.

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How quickly does leukemia, lymphocytic, chronic, b-cell spread?

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The median time to the start of first treatment (i.e. diagnosis of AML) is 13 months; this is much shorter than what was reported for ALL. Because the time to diagnosis of AML was correlated with the interval between diagnosis of first, non-solid tumor and solid tumor, we propose that diagnosis of AML is associated with an early onset of B-chronic lymphocytic leukemia.

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Does leukemia, lymphocytic, chronic, b-cell run in families?

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We found that patients with leukemic disorders do have a higher relative risk when there is a BCL2 mutation, an increased probability of development for other cancers, and an increased risk for family members. These data illustrate the importance of family history in the presentation of genetic predisposition associated with leukemic disorders.

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What are the chances of developing leukemia, lymphocytic, chronic, b-cell?

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Lymphocytic, chronic, b-cell patients have a higher possibility of developing leukemia, lymphocytic, chronic, b-cell. If you have this type of CLL/NOS and are over the average age of 50, seek urgent help. When you experience blood irregularities, contact your health care provider immediately.\n

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What are the latest developments in tg-1801 for therapeutic use?

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The most recent report on tg-1801 from the US FDA concludes that tg-1801 is well tolerated and does not have a myelocyte toxicity reaction in patients. There is evidence supporting the benefit of tg-1801 for both adult- and childhood-onset leukemia. Furthermore, studies in lymphoma and myeloid malignancies show that tg-1801 exhibits a high response rate and has favorable toxicity. The US FDA is currently evaluating submissions for a further use of tg-1801 for acute myeloid leukemia.

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Is tg-1801 typically used in combination with any other treatments?

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Tg-1801 is usually used in combination with chemotherapy. The combination regimen of Tg-1801 plus chemotherapy may provide enhanced clinical improvement in patients with non-Hodgkin's lymphoma.

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