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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.

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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....

Conditions Studied

Central Nervous System Lymphoma Secondary Central Nervous System Lymphoma

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

FieldValue
Enrollment Target 48 participants
Start Date 2019-06-27
Est. Completion 2028-07-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03964090

The ClinicalTrials.gov registry entry for NCT03964090 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 102-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (53% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.