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Ibrutinib + Chemotherapy for CNS Lymphoma
Study Summary
This trial is studying ibrutinib in combination with TEDDI-R to see how well it works in treating patients with primary central nervous system lymphoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have not had a stroke or brain bleed in the last 6 months.My lymphoma is in the brain or spinal cord and has not responded to treatment.I am 18 years old or older.I stopped taking ibrutinib at least 7 days before major surgery or 3 days before minor surgery.I have recovered from previous treatment side effects.I haven't taken strong CYP3A affecting drugs in the last 7 days.I do not have any uncontrolled illnesses.I need regular blood transfusions due to low platelet count.I haven't taken warfarin or similar medications in the last week.I haven't taken immunosuppressants, except for corticosteroids, in the last 28 days.I am willing and able to follow all study requirements.You've had allergic reactions to medicines similar to ibrutinib or other drugs being used in this study.I can care for myself but may not be able to do heavy physical work, except if my limitations are due to brain lymphoma.My organs and bone marrow work well without needing extra help.Your platelet count needs to be at least 50,000 cells/mcL (50 X 10(9)/L).My organ and bone marrow functions are normal.I have no lasting side effects from previous cancer treatments.I have uncontrolled autoimmune blood disorders.I stopped taking Ibrutinib 7 days before major surgery and will stop for 3 days before minor surgery.My diagnosis is primary CNS diffuse large B-cell lymphoma.I haven't received growth factors or transfusions in the last 7 days.I have had cancer before, but it might still be okay.You have a minimum level of hemoglobin of 8.0 g/dL.You are currently pregnant or breastfeeding.I have recovered from previous treatment side effects.I have a heart condition that affects my daily life.I do not have any severe illnesses or organ problems.I have been treated with a BTK inhibitor before.I have a known bleeding disorder.I have moderate to severe liver problems.My condition has returned or didn't respond to treatment.I cannot swallow pills or have major digestive issues.I have not had major surgery within the last week.It's been over 2 weeks since my last cancer treatment.You have enough neutrophil cells in your blood, specifically more than 750 cells per micro-liter.It has been over 2 weeks since my last cancer treatment.I can take care of myself but might not be able to do heavy physical work.I have not received any live vaccines in the last 4 weeks.
- Group 1: Arm 1-B (original study design-prior to Amendment G)
- Group 2: Arm 3 (Dose Expansion; prior to Amendment 06/04/2021)
- Group 3: Arm 1-A (original study design - prior to Amendment G)
- Group 4: Arm 4 (Dose Expansion; Amendment 06/04/21)
- Group 5: Arm 2 (Dose Escalation; prior to Amendment 06/04/2021)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What potential risks have been associated with TEDDI usage?
"Due to the preliminary nature of this phase 1 trial, we have assigned TEDDI a safety rating of 1. This is because there is limited evidence backing up its efficacy and safety so far."
What is the predominant use for TEDDI treatments?
"TEDDI is commonly used to treat DLBCL, and has also shown success in treating meningeal leukemia, SCLC and active pauciarticular juvenile rheumatoid arthritis."
Are any more participants being solicited for this research endeavor?
"Affirmative. Information hosted on clinicaltrials.gov attests to the fact that this experiment, first posted August 14th 2014, is presently recruiting participants. Ninety-three individuals need to be enrolled from two separate medical facilities."
How many participants are currently eligible for enrollment in this trial?
"Affirmative. Clinicaltrials.gov data supports that this clinical experiment is actively recruiting participants, which was initially posted on August 14th 2014 and recently updated November 1st 2022. A total of 93 people are sought from two separate medical sites."
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