Extension protocol for patients with Chronic Myelogenous Leukemia (CML), Malignant Melanoma (MM) or Renal Cell Carcinoma (RCC) that have responded to treatment with Pegylated-interferon a-2a (PEG-IFN) or Roferon-A in prior clinical studies.
- Conditions
- Treatment of CML, MM or RCC.
- Registration Number
- EUCTR2004-002093-30-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
- Patients must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol.
- CML patients must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC patients must have tumour assessments verifying stable or better response within 2 months of entering the extension study.
- Provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Pregnant or lactating women.
- Fertile men or women of childbearing potential unless
(1) surgically sterile or
(2) using adequate measures of contraception such as oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method