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Kinase Inhibitor

TGR-1202 for Chronic Lymphocytic Leukemia

Q: What medical purpose does TGR-1202 commonly serve?

<p>TGR-1202 is often employed to treat <a href="https://www.withpower.com/clinical-trials/follicular-lymphoma">follicular lymphoma</a>, as well as mantle cell and other varieties of this <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. Additionally, it may be given to patients that have received more than three different treatments in the past.</p>

Phase 1

Waitlist Available

Led By Matthew Davids, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)

Eastern Cooperative Group (ECOG) Performance status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will be testing a new drug called TGR-1202 in combination with ibrutinib, to see if it is a safe and effective treatment for CLL/SLL or MCL that has come back or stopped responding to standard treatments.

Who is the study for?

This trial is for adults with certain blood cancers (CLL, SLL, or MCL) that have relapsed or are treatment-resistant. Participants must be relatively active (ECOG ≤ 2), able to take oral meds, and not pregnant. They should have good organ function and can't join if they've had recent cancer treatments, stem cell transplants within specific timeframes, severe heart disease, other active cancers in the last 2 years, or uncontrolled medical conditions.Check my eligibility

What is being tested?

The study tests TGR-1202 combined with Ibrutinib's safety and effectiveness against chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or mantle cell lymphoma (MCL). It aims to find out how well these drugs work together for patients who haven't responded well to standard treatments.See study design

What are the potential side effects?

Possible side effects include digestive issues like nausea and diarrhea; liver problems indicated by abnormal blood tests; fatigue; potential infections due to low white blood cells; rash; muscle pain; and increased risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with MCL, CLL, or SLL.

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I can take care of myself and am up and about more than half of the day.

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I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I

Secondary outcome measures

Duration of Response

Overall Response Rate

Rate of Nodal Response With Lymphocytosis (nPR)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: MCLExperimental Treatment2 Interventions

Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Each Cycle = 28 days TGR-1202 (oral): Starting on Day 1 administered daily. Ibrutinib (oral): Starting on Day 1 administered daily.

Group II: CLLExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Umbralisib

FDA approved

Ibrutinib

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,903 Total Patients Enrolled

TG Therapeutics, Inc.Industry Sponsor

36 Previous Clinical Trials

5,586 Total Patients Enrolled

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

17,086 Total Patients Enrolled

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02268851 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: CLL, MCL

Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02268851 — Phase 1

Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02268851 — Phase 1

Frequently Asked Questions

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

What medical purpose does TGR-1202 commonly serve?

"TGR-1202 is often employed to treat follicular lymphoma, as well as mantle cell and other varieties of this cancer. Additionally, it may be given to patients that have received more than three different treatments in the past."

Answered by AI

Are there any vacancies available to participate in this medical experiment?

"As of August 29, 2022, this clinical trial has ceased recruiting candidates. It was originally posted on November 1st 2014 and later updated accordingly. For those searching for other trials to participate in; there are 2117 studies actively enrolling patients with lymphoma or mantle-cell cancers as well as 165 investigations involving TGR-1202 presently looking for participants."

Answered by AI

Has there been any further exploration of the efficacy of TGR-1202?

"In 2011, the initial trials for TGR-1202 were conducted at National Institutes of Health Clinical Center. Up to this date, 103 studies have been fully completed and 165 are still running with many taking place in Hartford Connecticut."

Answered by AI

What potential hazards does TGR-1202 pose to those participating in the trial?

"As a Phase 1 trial, there is limited evidence of TGR-1202's safety and efficacy. Thus, it was given an overall rating of 1 by our research team here at Power."

Answered by AI

Are there multiple sites in Canada that are administering this clinical trial?

"This trial is being run in 6 different clinical settings, including St. Francis Hospital and Cancer Center in Hartford, Dana Farber Cancer Institute in Boston, Beth Israel Deaconness Medical Center in Kalamazoo, as well other medical centres throughout the US."

Answered by AI

To what extent is participation being sought for this research endeavor?

"This trial is currently not enrolling any additional patients. The study was initially posted on November 1st 2014, and the latest edit was made on August 29th 2022. For those looking for alternate studies, there are 2117 clinical trials recruiting people with lymphoma or mantle-cell; in addition to 165 separate experiments seeking participants for TGR-1202."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Umbralisib in Combination with Ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukaemia or Mantle Cell Lymphoma: A Multicentre Phase 1–1b Study

Davids, Matthew S, Haesook T Kim, Alyssa Nicotra, Alexandra Savell, Karen Francoeur, Jeffrey M Hellman, Josie Bazemore, et al.. 2019. “Umbralisib in Combination with Ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukaemia or Mantle Cell Lymphoma: A Multicentre Phase 1–1b Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(18)30196-0.

clinicaltrials.govStudy

A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

Matthew S. Davids, MD 2014. "A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02268851.