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

• Status: Recruiting
• Trial end date: 2025-07-01

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....

• Phase: Phase 2

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: BB 1101; Cytarabine; Dexamethasone; Dexamethasone acetate; Etoposide; Etoposide phosphate; Isavuconazole; Liposomal doxorubicin; Methotrexate; Rituximab; Temozolomide