NCT03688451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5.1 years

First QC Date

September 26, 2018

Last Update Submit

March 28, 2023

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Ability to deliver greater than 80% of planned doses

    Percentage of planned doses administered for planned accrual

    28 months

  • Related Grade 3 or higher non-hematological toxicity

    Number of related grade 3 or higher non-hematological toxicities

    28 months

Study Arms (1)

Intrathecal rituximab

EXPERIMENTAL

Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5

Drug: Rituximab

Interventions

RituximabDRUG

Intrathecal administration over 3-5 minutes

Intrathecal rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Primary central nervous system lymphoma or established secondary central nervous system disease.
  • History of spinal surgery and/or ineligible for intrathecal injections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Health

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tahir Latif, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential dose cohorts
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

October 29, 2018

Primary Completion

December 1, 2023

Study Completion

October 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)