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Optimal Conditioning Regimen for Autologous Transplantation of Relapsing Remitting Multiple Sclerosis

NCT05482542 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-09

No results posted yet for this study

Summary

This study is designed to compare two non-myeloablative conditioning regimens (combination of chemotherapy and immune specific proteins against immune cells) for relapsing remitting multiple sclerosis (RRMS). The two conditioning regimens are the most commonly used world wide in clinical practice for the treatment of multiple sclerosis (MS). The first investigational conditioning regimen is cyclophosphamide (chemotherapy) and rATG (rabbit anti-thymocyte globulin, a protein against immune cells). The second investigational conditioning regimen includes the same dose of cyclophosphamide (chemotherapy) and rituximab (a protein against immune cells). Both cyclophosphamide and either rATG or rituximab are given to kill immune cells that are thought to be causing MS, followed by return of one's own previously collected blood stem cells (autologous stem cell transplant) to hasten recovery. The goal of this study is to assess the difference of these treatments in terms of toxicity and efficacy.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

OTHER

Autologous hematopoietic stem cell transplantation

Autologous hematopoietic stem cell transplantation

DRUG

Cyclophosphamide/ATG

Cyclophosphamide/ATG

DRUG

Cyclophosphamide/Rituximab

Cyclophosphamide/Rituximab

Sponsors & Collaborators

  • Scripps Health

    lead OTHER

Principal Investigators

  • David J Hermel, MD · Scripps Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482542 on ClinicalTrials.gov