CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 156 target
Drug / intervention
Best Available Therapy (BAT) +1 morebiological
Likely dose
Not stated in record
Key inclusion· 14
  • ✓Age 18 to 55 years at screening
  • ✓MS diagnosis per 2017 McDonald Criteria
  • ✓EDSS ≤6.0 at randomization
  • ✓T2 brain abnormalities meeting 2017 McDonald MRI dissemination criteria
Key exclusion· 39
  • ✕Primary progressive MS diagnosis
  • ✕History of neuromyelitis optica spectrum disorder or MOG antibody disease
  • ✕Prior investigational agent within 3 months or 5 half-lives
  • ✕Acute MS relapse within 1 month of randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04047628
NCT04047628Phase 3RecruitingOn TrackUpdated 5mo ago
Long Recruiting
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A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 7, 2019·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation and Best Available Therapy (BAT) for Relapsing Multiple Sclerosis and 2 related conditions. Currently recruiting, targeting 156 participants across 22 sites.

Detailed Summary

This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN), Blood and Marrow Transplant Clinical Trials Network, PPD Development, LP, Rho Federal Systems Division, Inc.

Timeline

Phase 3Recruiting
20202021202220232024202520262027202820292030
First PostedAug 7, 2019
Enrollment StartDec 19, 2019
Primary CompletionOct 1, 2026
Study CompletionOct 1, 2029
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 6.9 years agoPrimary completion in 3 months

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

1. PBSC mobilization \& collection regimen per protocol/ institutional standards includes: intravenous cyclophosphamide (Cytoxan®), 4 grams/m\^2); intravenous mesna (Mesnex®),a total delivery of 4 grams/m\^2); oral dexamethasone, 10 mg dose, four times daily); subcutaneous filgrastim,10 mcg/kg/day until leukapheresis goal is completed; and CD34+ peripheral blood stem cells collection by leukapheresis. 2. Conditioning per protocol\& institutional standards: * 6-day BEAM (e.g. Carmustine (BCNU), Etoposide (VP-16), Cytarbine (Ara-C), and Melphalan) chemotherapy protocol and, * rabbit anti-thymocyte globulin (rATG) 2.5 mg/kg/day x2 3. Autologous cryopreserved graft infusion: The target Cluster of Differentiation (CD)34+ cell dose for infusion is 5 x 10\^6 CD34+ cells/kg (minimum 4 x 10\^6 CD34+ cells/kg; maximum 7.5 x 10\^6 CD34+ cells/kg). For 1\&2 above: Ideal body weight (IBW) versus Actual Body Weight (ABW) are applicable.

Best Available Therapy (BAT)biological

Disease-modifying therapy (DMT) selected by the Site Investigator from the below: * cladribine * natalizumab * alemtuzumab * ocrelizumab, * rituximab, * ofatumumab, or * ublituximab