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Corticosteroid
Ibrutinib + Chemotherapy for CNS Lymphoma
Phase 1
Recruiting
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
Patients must have histologically or cytologically confirmed primary central nervous system diffuse large B-cell lymphoma. Only patients with relapsed or refractory disease are eligible. Patients with PCNSL that is only extracranial will not be eligible.
Ibrutinib must be discontinued 7 days before (when possible) until 7 days after major surgery, and 3 days before (when possible) until 3 days after minor surgery. Thus, patients to be enrolled on an ibrutinib trial must have completed major surgery greater than or equal to 7 days before initiating treatment, and/or must have completed minor surgery greater than or equal to 3 days before initiating treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after one cycle
Awards & highlights
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.
Who is the study for?
Adults diagnosed with primary central nervous system diffuse large B-cell lymphoma that has returned or resisted treatment. They must be at least 18 years old, not pregnant or breastfeeding, and have recovered from previous treatments. Participants need to have good organ function and cannot have used certain drugs recently.Check my eligibility
What is being tested?
The trial is testing the combination of Ibrutinib with a novel immuno-chemotherapy regimen (TEDDI-R) for brain lymphoma. The first phase determines the highest dose patients can tolerate or the dose needed to reach effective levels in spinal fluid without severe side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression, such as increased risk of infections, blood disorders, liver problems, heart issues, digestive disturbances due to chemotherapy components and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is in the brain or spinal cord and has not responded to treatment.
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I stopped taking ibrutinib at least 7 days before major surgery or 3 days before minor surgery.
Select...
My diagnosis is primary CNS diffuse large B-cell lymphoma.
Select...
I haven't received growth factors or transfusions in the last 7 days.
Select...
I have recovered from previous treatment side effects.
Select...
My condition has returned or didn't respond to treatment.
Select...
It has been over 2 weeks since my last cancer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initiation of ibrutinib until 30 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of ibrutinib until 30 days after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response rate in untreated PCNSL patients
MTD of ibrutinib when given with TEDD-R
MTD of ibrutinib with anti-fungal prophylaxis when given with TEDD-R
+1 moreSecondary outcome measures
Overall survival
Progression-free survival
Safety and Tolerability
Trial Design
5Treatment groups
Experimental Treatment
Group I: Arm 4 (Dose Expansion; Amendment 06/04/21)Experimental Treatment6 Interventions
TEDDI-R, cytarabine or methotrexate, isavuconazole, ibrutinib for 10 days
Group II: Arm 3 (Dose Expansion; prior to Amendment 06/04/2021)Experimental Treatment4 Interventions
TEDDI-R with cytarabine and isavuconazole
Group III: Arm 2 (Dose Escalation; prior to Amendment 06/04/2021)Experimental Treatment4 Interventions
TEDDI-R with cytarabine, and isavuconazole
Group IV: Arm 1-B (original study design-prior to Amendment G)Experimental Treatment3 Interventions
TEDDI-R with cytarabine
Group V: Arm 1-A (original study design - prior to Amendment G)Experimental Treatment7 Interventions
TEDD-R (cycle 1) with ibrutinib; TEDDI-R with cytarabine (cycles 2-6)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Isavuconazole
2020
Completed Phase 3
~1720
Rituximab
1999
Completed Phase 4
~1880
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,719 Previous Clinical Trials
40,963,465 Total Patients Enrolled
8 Trials studying Central Nervous System Lymphoma
428 Patients Enrolled for Central Nervous System Lymphoma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,071 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
48 Patients Enrolled for Central Nervous System Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
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.
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