NCT05482542

Optimal Conditioning Regimen for Autologous Transplantation of Relapsing Remitting Multiple Sclerosis

Optimal Conditioning Regimen Protocol for Autologous Hematopoietic Stem Cell Transplantation of Relapsing Remitting Multiple Sclerosis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Autologous hematopoietic stem cell transplantation (HSCT) in patients with active relapsing remitting multiple sclerosis (RRMS) halts disease progression, improves neurologic disability and quality of life, and provides a prolonged drug-free remission. A "position paper" by neurologists and hematologists under the American Society of Transplant and Cellular Therapy (ASTCT) has recommended autologous HSCT as standard of care, clinical evidence available, for treatment-refractory relapsing MS with high risk of future disability. Similarly, the EBMT has recommended the use of HSCT as "standard or care" for patients with highly active RRMS failing at least one DMT. Currently, the optimal conditioning regimen in terms of safety and efficacy is unknown. Herein, we will compare the two most commonly used regimens cyclophosphamide/ATG, or cyclophosphamide/rituximab in terms of safety and efficacy.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
OTHER	Autologous hematopoietic stem cell transplantation	Autologous hematopoietic stem cell transplantation
DRUG	Cyclophosphamide/ATG	Cyclophosphamide/ATG
DRUG	Cyclophosphamide/Rituximab	Cyclophosphamide/Rituximab

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-08-01
• Last updated: 2023-11-09

Locations

1 site across 1 country: United States