A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | August 2006 |
| End Date: | November 2011 |
Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a
maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit
from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or
significant adverse events. Patients will receive their most effective maintenance dose
until disease progression or significant toxicity occurs.
maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit
from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or
significant adverse events. Patients will receive their most effective maintenance dose
until disease progression or significant toxicity occurs.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Evidence of improvement of one or more clinical benefit criteria with acceptable
tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit
in MRA004US, and completion of MRA004US
- Life expectancy > 12 weeks
- Zubrod performance status
Exclusion Criteria:
- Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US
trial
- Any treatment for Multicentric Castleman's Disease except for corticosteroids within
2 weeks prior to Day 1
- Active infection requiring iv antibiotics for > 1 month and not resolving at least 1
week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous
access portals is allowed
- Active viral infection within 28 days prior to Day 1
- Treatment with any investigational agent other than RoActemra/Actemra within 30 days
prior to baseline
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