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Anti-tumor antibiotic
TEDDI-R for Central Nervous System Lymphoma
Phase 2
Waitlist Available
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women age greater than or equal to18 years. NOTE: Because no dosing or adverse event data are currently available on the use of ibrutinib and TEDDI-R in participants <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
Participants must have histologically or cytologically confirmed secondary involvement of an aggressive B-cell lymphoma in the CNS (eye, CSF, and/or brain parenchyma).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 cycles during treatment; every 3-6 months in follow-up
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is more effective in treating secondary central nervous system lymphoma than the current standard of care.
Who is the study for?
Adults aged 18+ with secondary central nervous system lymphoma (sCNSL) are eligible. They must have certain blood levels, organ function within specific ranges, and no recent chemotherapy or strong drug interactions. Women of childbearing age need a negative pregnancy test and must use effective birth control methods.Check my eligibility
What is being tested?
The TEDDI-R regimen is being tested for treating aggressive B-cell lymphomas that have spread to the CNS. The trial involves taking drugs orally or through catheters over cycles of 21 days, with up to four treatment cycles followed by regular check-ups.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion process, impact on blood cells leading to disorders like anemia or clotting issues, liver function changes, fatigue, infection risk increase due to immune suppression, and possible digestive system disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My aggressive B-cell lymphoma has spread to my CNS, including possibly my eye, brain, or CSF.
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I can take care of myself, but I might not be able to do heavy physical work.
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My organs are functioning well without needing transfusions.
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I am a man and will use contraception and not donate sperm during and for 12 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 cycles during treatment; every 3-6 months in follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 cycles during treatment; every 3-6 months in follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Assessment of pharmacokinetics (PK) and safety of TEDDI-R with concomitant anti-fungal prophylaxis
Best overall response after 14 days of ibrutinib monotherapy in sCNSL; after up to 4 cycles of TEDDI-R; and, after up to 4 cycles of TEDD-R (no ibrutinib)
Duration of response (DOR)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment6 Interventions
Temozolomide, etoposide, doxil, dexamethasone, and rituximab without ibrutinib (TEDD-R) or TEDD-R with ibrutinib Days 1-10 (TEDDI-R), concurrent with cytarabine and isavuconazole, based upon response to 14-day ibrutinib window
Group II: 1Experimental Treatment5 Interventions
Temozolomide, etoposide, doxil, dexamethasone, and rituximab without ibrutinib (TEDD-R) or TEDD-R with ibrutinib (TEDDI-R), concurrent with cytarabine and isavuconazole, based upon response to 14-day ibrutinib window
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Cytarabine
2016
Completed Phase 3
~3310
Isavuconazole
2020
Completed Phase 3
~1720
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,105 Total Patients Enrolled
7 Trials studying Central Nervous System Lymphoma
380 Patients Enrolled for Central Nervous System Lymphoma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,124 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV.I am 18 years old or older.I can understand and am willing to sign the consent form.I cannot swallow pills or have serious digestive system issues.My aggressive B-cell lymphoma has spread to my CNS, including possibly my eye, brain, or CSF.I do not have serious heart problems or recent heart attacks.Your hemoglobin level should be 8 g/dL or higher, and you are allowed to have blood transfusions to reach this level.Your blood test shows that there are enough infection-fighting white blood cells in your body.You should have at least 50,000 platelet cells per microliter of blood.I don't have any serious illnesses or infections that aren't under control.My kidney function is within the required range.My early-stage cancer was treated and shows no signs of being present now.I have not received any live vaccines in the last 4 weeks.I can take care of myself, but I might not be able to do heavy physical work.Your total bilirubin level in the blood should be equal to or less than 1.5 times the upper limit of normal, unless you have Gilbert's syndrome or a disease that affects your liver.Your AST and ALT levels must be equal to or lower than three times the highest level considered normal at the clinic. If you have liver involvement due to lymphoma, your levels must be equal to or lower than five times the highest level considered normal at the clinic.My organs are functioning well without needing transfusions.I haven't taken strong drugs that affect liver enzymes in the last week.I am using effective birth control or practicing abstinence as required.I am a man and will use contraception and not donate sperm during and for 12 months after the study.I do not have active hepatitis B or C, or I am being treated and monitored for it.I have side effects from cancer treatment that haven't fully gone away, except for hair loss.I have a bleeding disorder like von Willebrand's disease or hemophilia.I need regular blood transfusions due to low platelet counts.I had skin cancer (not melanoma) or lentigo maligna treated and currently show no signs of the disease.I agree to use effective birth control or barrier methods during the study.You have a medical condition that is life-threatening or could make participating in the study risky. If there are signs of aspergillosis infection in your chest or brain, you will not be eligible unless lab tests show that you do not have the infection.I haven't taken any immune-suppressing drugs (other than steroids) in the last 28 days.You are allergic to isavuconazole or any of its parts.I am willing and able to follow all study requirements.My previously slow-growing lymphoma now affects my brain or spinal cord.I haven't had chemotherapy in the last 14 days.I have not had a stroke or brain bleed in the last 3 months.I haven't taken warfarin or similar medications in the last week.You have had an allergic reaction to drugs that are similar to ibrutinib or other drugs used in this study.I do not have significant liver problems.I am not pregnant or breastfeeding.My DLBCL has returned or didn't respond to treatment, or it's my first treatment and my eyes, CSF, or brain are affected.I am 18 years old or older.I have had cancer before, but it was a type that is allowed in this trial.I am not pregnant or cannot become pregnant.My cancer was treated over 2 years ago, and my doctor believes it's unlikely to come back.My previously slow-growing lymphoma now affects my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
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.
How many participants are included in this trial?
"Affirmative. According to the data hosted on clinicaltrials.gov, this research is currently recruiting participants and was first posted on June 27th 2019. As of November 10th 2022, 65 volunteers from a single medical site are needed for completion of this project."
Answered by AI
Has the FDA sanctioned TEDD-R for public use?
"Our team at Power judged the safety of TEDD-R to be a 2, as there is some existing data affirming its overall security yet none that confirms its efficacy."
Answered by AI
Is enrollment for this trial open to potential participants?
"Affirmative. The clinical trial can be found on the public database, with an initial post date of June 27th 2019 and a recent update made November 10th 2022. 65 participants are sought at one medical site."
Answered by AI
What conditions has the TEDD-R system been employed to assist with?
"TEDD-R is the most popular treatment option for small cell lung cancer (SCLC) and has been seen to be effective in managing active pauciarticular juvenile rheumatoid arthritis, head and neck carcinoma, as well as multiple sclerosis."
Answered by AI
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