MDACC Study Summary 2011-0844

Study Summary
No. 2011-0844:.......Leukemia......Elias Jabbour......Leukemia

Study Summary Title



Study Summary Number:	2011-0844

Study Title:	Safety and Efficacy of Intrathecal Rituximab in Patients with Lymphoid Malignancies Involving the Central Nervous System

Physician

New Patient Referral



Name:	Elias Jabbour	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-4764 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	Rituximab	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:

Description/
Intervention:

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 Objectives / Outcomes

To determine the safety and efficacy of intrathecal rituximab in patients with relapsed and/or refractory lymphoid malignancies with involvement of the central nervous system.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/24/2013

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

3) Patients with prior neuraxis radiotherapy are excluded.

4) Patients are excluded for any prior history of whole-brain or cranio-spinal irradiation or any current need for whole-brain or cranio-spinal irradiation. A need for focused radiation therapy to a portion of the spine will not make patients ineligible.

Links

Registration Number: NCT01596127
Study Information on Clinical Trials Registry (clinicaltrials.gov)