CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 4 enrolled
Drug / intervention
Intrathecal Rituximabdrug
Likely dose
Intrathecal Rituximab 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01596127
NCT01596127Phase 2Terminated
Terminated
CompareCT.gov

Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System

M.D. Anderson Cancer Center·interventional·Posted May 10, 2012·Updated May 24, 2018

In Brief

A Phase 2 clinical trial evaluating Intrathecal Rituximab for Leukemia and 2 related conditions. Terminated early, enrolled 4 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

The goal of this clinical research study is to learn about the safety and effectiveness of rituximab given by spinal tap in patients with lymphoid malignancies involving the central nervous system. A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is collected by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure. It will also be used to give chemotherapy in this study. Rituximab is designed to bind to a protein, called CD20, that is on the surface of the leukemia cells. This may cause the leukemia cells to die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoid Malignancies, Metastatic Malignant Neoplasm to the Leptomeninges
CountriesUnited States
Collaborators--

Timeline

Phase 2TerminatedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartJan 24, 2013
Primary CompletionMar 23, 2017
TodayJul 1, 2026
Enrollment to primary: 4.2 yearsPosted 14.1 years ago

Interventions

Intrathecal Rituximabdrug

Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks. Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.