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NCT03964090 · ClinicalTrials.gov registry record · Phase 2
Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)
A Phase 2 study of Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03964090: Active Phase 2 study of Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, sponsored by National Cancer Institute (NCI).
NCT03964090 is a Phase 2 study of Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 102-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03964090, a Phase 2 study of Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Secondary central nervous system lymphoma (sCNSL) is cancer that has spread to the central nervous system. Most drugs used to treat it do not cross the blood-brain barrier. This makes it hard to treat. Researchers hope that a new combination of drugs may be able to help. Objective: To find a better way to treat sCNSL. Eligibility: People ages 18 and older with sCNSL Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Eye exam * Tissue or tumor biopsy * Collection of cerebrospinal fluid * CT, PET, and MRI scans: Participants will like in a machine that takes pictures of the body. * Bone marrow aspirations or biopsies: A needle will be inserted into the participant s hipbone. The needle will remove a small amount of marrow. Participants will take the study drugs in 21-day cycles. They will take some drugs by mouth. They will take others through a catheter: A small tube will be inserted into a vein in the arm, neck, or chest. They may have drugs given through a catheter placed through the brain or injected into the spinal canal. Participants will have regular visits during the study. These will include repeats of the screening test. They may also provide a saliva sample or have a cheek swab. Participants will have up to 4 treatment cycles. Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for 3 years and then yearly....
Primary Outcome
time from study enrollment until disease progression or death from any cause by arm
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Ibrutinib
- DRUG Isavuconazole
- DRUG TEDD-R
- DRUG TEDDI-R
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
What the registry record for NCT03964090 still lists
NCT03964090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 102-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Central Nervous System Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cytarabine is the first listed.
NCT03964090 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03964090 about?
NCT03964090 is a clinical study titled "Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)". Background: Secondary central nervous system lymphoma (sCNSL) is cancer that has spread to the central nervous system. Most drugs used to treat it do not cross the blood-brain barrier. This makes it hard to treat. Researchers hope that a new combination of drugs may be able to help. Objective: To...
What is the current status of trial NCT03964090?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2019-06-27. Estimated completion is 2028-07-01.
What conditions does trial NCT03964090 study?
This clinical trial studies the following conditions: Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT03964090?
The interventions under investigation include: Cytarabine (DRUG), Ibrutinib (DRUG), Isavuconazole (DRUG), TEDD-R (DRUG), TEDDI-R (DRUG).
Who is sponsoring clinical trial NCT03964090?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03964090 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03964090's enrollment target sits among peer trials
48 9th of 14 higher than 6 of 14 other Central Nervous System Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Central Nervous System Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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