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Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

NCT03964090 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-30

No results posted yet for this 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

  • Central Nervous System Lymphoma
  • Secondary Central Nervous System Lymphoma

Interventions

DRUG

TEDD-R

Temozolomide, etoposide, doxil, dexamthasone, and rituximab (TEDD-R) given every 21 days for cycles 1-4

DRUG

TEDDI-R

Temozolomide, etoposide, doxil, dexamthasone, ibrutinib and rituximab (TEDDI-R) given every 21 days for cycles 1-4

DRUG

Ibrutinib

For Arm 1:Ibrutinib given on days -14 to day -1 prior to cycle 1;then given every 21 days for cycles 1-4 For Arm 2: Ibrutinib given on days -14 to day -1 prior to cycle 1; then on days 1-10 for cycles 1-4

DRUG

Cytarabine

Cytarabine on days 1 and day 5 of cycles 2-5 (all arms), as applicable

DRUG

Isavuconazole

Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy unless ibrutinib discontinued permanently

DRUG

Methotrexate

Methotrexate on days 1 and day 5 of cycles 2-5 (all arms), as applicable

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Rahul Lakhotia, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2027-07-01
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964090 on ClinicalTrials.gov