Viewing Study NCT01596127



Ignite Creation Date: 2024-05-06 @ 12:31 AM
Last Modification Date: 2024-10-26 @ 10:51 AM
Study NCT ID: NCT01596127
Status: TERMINATED
Last Update Posted: 2018-05-24
First Post: 2012-05-08

Brief Title: Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System
Sponsor: MD Anderson Cancer Center
Organization: MD Anderson Cancer Center

Study Overview

Official Title: Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System
Status: TERMINATED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Slow Accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Study Groups and Study Drug Administration

If you are found to be eligible you will be assigned to a study group based on when you join this study Up to 12 participants will be enrolled in the Phase I portion of the study and up to 13 participants will be enrolled in Phase II

If you are enrolled in the Phase I portion the dose of rituximab you receive will depend on when you joined this study The first group of participants will receive the lowest dose level of rituximab Each new group will receive a higher dose of rituximab than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of rituximab is found

If you are enrolled in the Phase II portion you will receive rituximab at the highest dose that was tolerated in the Phase I portion

Study Visits

Once enrolled you will return to the clinic and receive the study drug by spinal tap up to 2 times a week You will receive treatment twice a week until 2 CSF samples in a row do not show any leukemia cells After that you will receive treatment 1 time a week for an additional 4 weeks and then you will receive treatment once every other week for an additional 8 weeks The number of doses you receive will depend on how many doses the study doctor thinks is needed

At each study visit the following procedures will be performed

You will have a physical exam including measurement of your weight and vital signs Your vital signs will be measured every 15 minutes for 1 hour after each dose of rituximab
You will be asked how well you are able to perform the normal activities of daily living performance status
You will be asked about any drugs you may be taking and any side effects you may experiencing
Blood about 2 tablespoons will be drawn for routine tests
A sample of cerebral spinal fluid may be collected from the lumbar puncture to verify the absence or presence of blast cells

Follow-Up

About 30 days after your last dose of study drug you will be contacted by the study staff by telephone and asked about any drugs you may be taking and any side effects you may experiencing This call should take about 10 minutes

Long-term Follow-up

Every 6 to 12 months you may be contacted by the study staff by telephone and asked about any drugs you may be taking and any side effects you may experiencing This call should take about 10 minutes

You may be given other drugs to help prevent side effects The study staff will tell you about these drugs how they will be given and the possible risks

Length of Treatment

The number of treatments you receive will depend on how long it takes for there to be no leukemia cells in the CSF samples Once this happens you will have treatments for an additional 12 weeks You will no longer be able to take the study drug if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions

This is an investigational study Rituximab is FDA approved and commercially available for the treatment of relapsed andor refractory lymphoid malignancies involving the central nervous system Receiving rituximab by spinal tap is considered investigational

Up to 25 patients will take part in this study All will be enrolled at MD Anderson

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-2012-00849 REGISTRY NCI CTRP None