Your session is about to expire
← Back to Search
Syk Inhibitor
Tirabrutinib Combination Therapy for B-Cell Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL) meeting International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria 2008, mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia (WM), or non-germinal center B-cell lymphoma (GCB) diffuse large B-cell lymphoma (DLBCL) as documented by medical records on World Health Organization (WHO) criteria
Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years from the date of protocol amendment 8
Awards & highlights
Study Summary
This trial is studying the safety and effectiveness of a new drug, tirabrutinib, when combined with other targeted anti-cancer therapies, as well as the long-term safety of tirabrutinib when used as a monotherapy or in combination with other targeted anti-cancer therapies, in adults with relapsed or refractory B-cell lymphoproliferative malignancies.
Who is the study for?
Adults with certain types of B-cell lymphoma who've had at least one prior treatment and aren't eligible for a transplant can join. They should have measurable disease, adequate blood counts, liver and kidney function within set limits, not be pregnant, and agree to pneumonia prophylaxis.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Tirabrutinib in combination with other cancer drugs (Idelalisib, Entospletinib, Obinutuzumab) for relapsed or refractory B-cell malignancies. It includes dose escalation/expansion phases and long-term safety monitoring.See study design
What are the potential side effects?
Potential side effects may include digestive issues, liver enzyme changes, fatigue, infections due to low blood cell counts. Specific side effects will depend on the drug combinations used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of lymphoma or leukemia.
Select...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have a tumor larger than 2.0 cm long and 1.0 cm wide, not including Waldenstrom's macroglobulinemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years from the date of protocol amendment 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years from the date of protocol amendment 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) at Week 12 During the Dose Expansion Phase for Non-CLL Participants
Overall Response Rate (ORR) at Week 24 During the Dose Expansion Phase for CLL Participants
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) During the Dose Escalation Phase
+1 moreSecondary outcome measures
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
For Participants with Chronic Lymphocytic Leukemia (CLL) Only: Proportion of Participants who Achieve Minimal Residual Negative Disease (< 1 leukemia cell/10,000 leukocytes) During the Dose Escalation Phase and Dose Expansion Phase
Overall Response Rate (ORR) During the Dose Escalation Phase and Dose Expansion Phase
+4 moreSide effects data
From 2019 Phase 2 trial • 152 Patients • NCT0310094211%
Alanine aminotransferase increased
11%
Arthralgia
11%
Rash
11%
Upper respiratory tract infection
11%
Aspartate aminotransferase increased
11%
Fatigue
8%
Gastroenteritis viral
8%
Nasopharyngitis
8%
Diarrhoea
8%
Dizziness
8%
Pyrexia
5%
Laryngitis
5%
Lower respiratory tract infection
5%
Oral herpes
5%
Sinusitis
5%
Myalgia
5%
Dental caries
5%
Neutropenia
5%
Pruritus generalised
5%
Lymphadenopathy
5%
Bronchitis
5%
Nausea
5%
Vomiting
3%
Rheumatoid arthritis
3%
Fall
3%
Acute coronary syndrome
3%
Pancreatitis acute
3%
Suicidal ideation
3%
Seasonal allergy
3%
Furuncle
3%
Influenza
3%
Urinary tract infection
3%
Osteoarthritis
3%
Migraine
3%
Hyperhidrosis
3%
Anaemia
3%
Back pain
3%
Rash pruritic
3%
Insomnia
3%
Musculoskeletal pain
3%
Rash papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo to Tirabrutinib
Placebo on Placebo Controlled Period
Lanraplenib
Filgotinib
Tirabrutinib
Placebo to Lanraplenib
Placebo to Filgotinib
Trial Design
5Treatment groups
Experimental Treatment
Group I: Tirabrutinib + Idelalisib + Obinutuzumab (Combination III)Experimental Treatment3 Interventions
Dose escalation:
Participants will receive tirabrutinib + idelalisib + obinutuzumab 1000 mg at 8 doses (tirabrutinib and idelalisib doses will depend on results of Combination I data). Based on DLTs observed, additional participants will be enrolled to determine the maximum tolerated dose (MTD) of tirabrutinib either once daily or twice daily.
Dose Expansion:
Additional participants will receive tirabrutinib + idelalisib + obinutuzumab for an additional 6 years from the date of Protocol Amendment 8.
Group II: Tirabrutinib + Idelalisib (Combination I)Experimental Treatment2 Interventions
Dose Escalation:
Participants will receive a single dose of tirabrutinib on Day 1 of Cycle 1 and tirabrutinib 20 mg + idelalisib 50 mg on Day 2 and remainder of Cycle 1. For all subsequent cycles, participants will receive tirabrutinib 20 mg + idelalisib 50 mg. Based on DLTs observed in subsequent cohorts, additional participants will be enrolled and administered escalating dose of tirabrutinib up to 160 mg + idelalisib up to 100 mg to determine the maximum tolerated dose (MTD) of tirabrutinib either once daily or twice daily.
Dose Expansion:
Additional participants will receive tirabrutinib + idelalisib for an additional 6 years from the date of Protocol Amendment 8.
Group III: Tirabrutinib + Entospletinib + Obinutuzumab (Combination IV)Experimental Treatment3 Interventions
Dose escalation:
Participants will receive tirabrutinib + entospletinib + obinutuzumab 1000 mg at 8 doses (tirabrutinib and entospletinib doses will depend on results of Combination II data). Based on DLTs observed, additional participants will be enrolled to determine the maximum tolerated dose (MTD) of tirabrutinib either once daily or twice daily.
Dose Expansion:
Additional participants will receive tirabrutinib + idelalisib + obinutuzumab for an additional 6 years from the date of Protocol Amendment 8.
Group IV: Tirabrutinib + Entospletinib (Combination II)Experimental Treatment2 Interventions
Dose Escalation:
Participants will receive a single dose of tirabrutinib 40 mg on Day 1 of Cycle 1 and tirabrutinib 40 mg + entospletinib 200 mg on Day 2 and remainder of Cycle 1. For all subsequent cycles, participants will receive tirabrutinib 40 mg + entospletinib 200 mg. Based on DLTs observed in subsequent cohorts, additional participants will be enrolled and administered escalating dose of tirabrutinib up to 160 mg + entospletinib up to 400 mg to determine the maximum tolerated dose (MTD) of tirabrutinib either once daily or twice daily.
Dose Expansion:
Additional participants will receive tirabrutinib + entospletinib for an additional 6 years from the date of Protocol Amendment 8.
Group V: Single Agent Tirabrutinib (Combination V)Experimental Treatment1 Intervention
Participants with relapsed or refractory chronic lymphocytic leukemia (CLL) may be enrolled to receive tirabrutinib 80 mg once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirabrutinib
2012
Completed Phase 2
~390
Idelalisib
2017
Completed Phase 3
~1660
Entospletinib
2017
Completed Phase 2
~120
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,550 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,544 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's electrical activity (QTc interval) is longer than normal.I have been diagnosed with a specific type of lymphoma or leukemia.I have had at least 2 treatments for my lymphoma and my disease did not improve or got worse.I haven't had blood transfusions or growth factor injections in the last week.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am willing and able to follow the treatment plan to prevent a specific type of pneumonia.I am currently or was previously enrolled in Study GS-US-401-1787 or GS-US-401-1757 and still receiving treatment.I have tested positive for hepatitis B.I am able to get out of my bed or chair and move around.I have a tumor larger than 2.0 cm long and 1.0 cm wide, not including Waldenstrom's macroglobulinemia.My cancer has shown signs of getting worse either through symptoms or imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Single Agent Tirabrutinib (Combination V)
- Group 2: Tirabrutinib + Idelalisib + Obinutuzumab (Combination III)
- Group 3: Tirabrutinib + Idelalisib (Combination I)
- Group 4: Tirabrutinib + Entospletinib (Combination II)
- Group 5: Tirabrutinib + Entospletinib + Obinutuzumab (Combination IV)
Awards:
This trial has 1 awards, including:- 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 there any prior investigations into the effects of Tirabrutinib?
"Initially studied back in 2014 at Dana-Farber Cancer Institute, tirabrutinib has seen 78 clinical trials reach completion. At present time there are 111 open studies being conducted with a significant presence of Washington D.C research centres involved in the effort."
Answered by AI
Is this the inaugural clinical trial of its kind?
"Since Tirabrutinib's inaugural clinical trial in 2014, Gilead Sciences has sponsored 111 active studies that span countries and cities across the globe. After 50 participants were tested for its safety, it was approved for Phase 2 drug trials."
Answered by AI
Has the Federal Drug Administration (FDA) sanctioned Tirabrutinib for medical use?
"The safety of Tirabrutinib is estimated to be a 1, as this clinical trial is at the earliest developmental stage and has scant evidence backing its efficacy."
Answered by AI
What indications is Tirabrutinib commonly utilized to treat?
"Tirabrutinib is normally used to treat refractory follicular lymphoma, but it has been demonstrated as an effective treatment for relapsed chronic lymphocytic leukemia, lymphoid leukemia, and a variety of B-cell based malignancies."
Answered by AI
How many individuals have enrolled in this clinical trial?
"At this juncture, the trial is not currently enrolling patients. This specific study was initially listed on June 16th 2015 and revised on June 29th 2022. For those in search of other trials, 2379 clinical studies are actively recruiting for B-cell malignancies while 111 different research projects need participants to test Tirabrutinib."
Answered by AI
What is the availability of enrollment in this experiment?
"Unfortunately, this medical trial is no longer recruiting. It was first posted on June 16th 2015 and last updated on June 29th 2022. For those seeking other studies, 2379 trials for b-cell malignancies are currently enrolling patients as well as 111 Tirabrutinib related clinical trials that accept participant applications now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger