A Phase I/II Study of Pixantrone in Patients with an Aggressive Relaps
A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS)
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Pixantrone
DNA cross-linking agent
What it measured
Main measures
1. Proportion of patients with a lymphopenia ≤ 1000/mm³ at month 3.
Who could take part
Relapsing and progressive
Show the full criteria
Inclusion criteria
Inclusion: 1. patients with aggressive RR or SP MS who failed to respond to approved immunomodulatory drugs (interferons beta, glatiramer acetate) and who cannot or do not wish to receive mitoxantrone or tysabri. Exclusion: 1. previous treatment with immunosuppressants (Mitoxantrone or other anthracyclines, Cyclophosphamide, Methotrexate, Azathioprine, rituximab, alemtuzumab …) in the past year
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
1. To determine if four consecutive administrations of 120 mg/m² each of PIX (equivalent to 12 mg/m² mitoxantrone) will provide an effective immunosuppression as reflected by a lymphopenia ≤ 1000/mm³ after completion of PIX administration.
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History
- Status changed from Ongoing to Status unknown
- Result signal changed from Ongoing to Status unknown
Started
Nov 2007