Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01596127
Recruitment Status : Terminated (Slow Accrual)
First Posted : May 10, 2012
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoid Malignancies Metastatic Malignant Neoplasm to the Leptomeninges Drug: Intrathecal Rituximab Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System
Actual Study Start Date : January 24, 2013
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intrathecal Rituximab

Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.

Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.

Drug: Intrathecal Rituximab

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.

Other Name: Rituxan

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Response assessed after minimum 2 weeks/4 treatments (2 twice weekly treatments) ]
    The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.

Secondary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Rituximab [ Time Frame: 2 weeks ]
    MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have relapsed or refractory CD20+ lymphoid malignancies with either documented CNS involvement or peripheral nerve infiltration.
  2. Patients 3 years of age and older are eligible after 3 patients (age 15 or older) have been treated and did not experience a dose limiting toxicity. Patient 3 to 15 years of age will follow the dose escalation schema independent of the adults.
  3. ECOG performance status measure will be used. (ECOG Performance Status less than or equal to 3)
  4. Adequate liver function (bilirubin less than or equal to 3 mg/dL within 24 hours of enrollment)
  5. Adequate renal function (serum creatinine less than or equal to 3 mg/dL within 24 hours of enrollment)
  6. Urine pregnancy test for women of childbearing potential (defined as not post-menopausal for 12 consecutive months or no previous surgical sterilizations). A negative urine pregnancy test is required within 48 hours of initiating study drug.
  7. Signed informed consent

Exclusion Criteria:

  1. Known active meningeal infection
  2. History of severe infusion reaction to any monoclonal antibody

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01596127

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Elias Jabbour, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol  [PDF] April 4, 2012
Statistical Analysis Plan  [PDF] April 4, 2012

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01596127     History of Changes
Other Study ID Numbers: 2011-0844
NCI-2012-00849 ( Registry Identifier: NCI CTRP )
First Posted: May 10, 2012    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
relapsed CD20+ lymphoid malignancies
refractory CD20+ lymphoid malignancies
Intrathecal Rituximab
Leptomeningeal disease
central nervous system disease
Relapsed lymphoid malignancies
refractory lymphoid malignancies
CNS leukemia
intrathecal chemotherapy
cerebrospinal fluid
lumbar puncture

Additional relevant MeSH terms:
Neoplasms, Second Primary
Meningeal Carcinomatosis
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents