Description:
The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.
The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Rituximab | Intrathecal rituximab |
Name | Type | Description | Interventions |
---|---|---|---|
Intrathecal rituximab | Experimental | Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5 |
|
Inclusion Criteria: - CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy. Exclusion Criteria: - Primary central nervous system lymphoma or established secondary central nervous system disease. - History of spinal surgery and/or ineligible for intrathecal injections.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Ability to deliver greater than 80% of planned doses |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Percentage of planned doses administered for planned accrual |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tahir Latif |
October 28, 2019