Optimal Conditioning Regimen for Autologous Transplantation of Relapsing Remitting Multiple Sclerosis

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT05482542
Status
Withdrawn

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex
ALL
Age
18 Years - 58 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous hematopoietic stem cell transplantation — OTHER
    Autologous hematopoietic stem cell transplantation
  • Cyclophosphamide/ATG — DRUG
    Cyclophosphamide/ATG
  • Cyclophosphamide/Rituximab — DRUG
    Cyclophosphamide/Rituximab

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Dec 2022
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Cyclophosphamide/ATG Conditioning Regimen
    Cyclophosphamide (200 mg /kg) / rabbit antithymocyte globulin (6.0 mg/kg)
  • Other: Cyclophosphamide/Rituximab Conditioning Regimen
    Cyclophosphamide (200 mg/kg) / rituximab (1000 mg).

Primary Outcome Measure

Durability of remission between two arms [ Time Frame: Time to first confirmed acute relapse or 5 years after treatment which ever comes first ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Green HospitalLa JollaCalifornia92037-

Find similar trials in La Jolla, CA

By research site
Scripps Green Hospital· La Jolla, CA

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