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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.
Must not have
Uncontrolled intercurrent illness
Presence of transfusion-dependent thrombocytopenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after one cycle
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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My diagnosis is primary CNS diffuse large B-cell lymphoma.
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I haven't received growth factors or transfusions in the last 7 days.
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I have recovered from previous treatment side effects.
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My condition has returned or didn't respond to treatment.
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It has been over 2 weeks since my last cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses.
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I need regular blood transfusions due to low platelet count.
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I am willing and able to follow all study requirements.
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I have no lasting side effects from previous cancer treatments.
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I have uncontrolled autoimmune blood disorders.
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I have a heart condition that affects my daily life.
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I do not have any severe illnesses or organ problems.
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I have been treated with a BTK inhibitor before.
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I have a known bleeding disorder.
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I have moderate to severe liver problems.
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I cannot swallow pills or have major digestive issues.
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I have not had major surgery within the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of ibrutinib until 30 days after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of ibrutinib until 30 days after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
Overall survival
Progression-free survival
Safety and Tolerability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3330
Isavuconazole
2020
Completed Phase 3
~1720
Rituximab
1999
Completed Phase 4
~2990
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,111,994 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
2,418 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
48 Patients Enrolled for Central Nervous System Lymphoma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02203526 — Phase 1
Central Nervous System Lymphoma Research Study Groups: Arm 1-B (original study design-prior to Amendment G), Arm 3 (Dose Expansion; prior to Amendment 06/04/2021), Arm 1-A (original study design - prior to Amendment G), Arm 4 (Dose Expansion; Amendment 06/04/21), Arm 2 (Dose Escalation; prior to Amendment 06/04/2021)
Central Nervous System Lymphoma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02203526 — Phase 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02203526 — Phase 1
~4 spots leftby Jun 2025
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