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Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688451
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Tahir Latif, University of Cincinnati

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential dose cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Intrathecal rituximab
Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
Drug: Rituximab
Intrathecal administration over 3-5 minutes




Primary Outcome Measures :
  1. Ability to deliver greater than 80% of planned doses [ Time Frame: 28 months ]
    Percentage of planned doses administered for planned accrual

  2. Related Grade 3 or higher non-hematological toxicity [ Time Frame: 28 months ]
    Number of related grade 3 or higher non-hematological toxicities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03688451


Contacts
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Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 cancer@uchealth.com

Locations
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United States, Ohio
UC Health Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute Clinical Trials Office    513-584-7698    cancer@uchealth.com   
Principal Investigator: Tahir Latif, MD         
Sponsors and Collaborators
Tahir Latif
Investigators
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Principal Investigator: Tahir Latif, MD University of Cincinnati
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Responsible Party: Tahir Latif, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03688451    
Other Study ID Numbers: UCCI-HEM-17-01
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents