A study of GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (a type of cancer)
- Conditions
- Health Condition 1: null- Advanced Stage FollicularLymphomaHealth Condition 2: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2012/04/002587
- Lead Sponsor
- Hexal AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 618
Key Inclusion Criteria:
1. Patient with previously untreated advanced stage, CD20-positive FL
2. Patient with ECOG performance status 0, 1 or 2.
Other protocol-defined inclusion criteria will apply
Key Exclusion Criteria:
1. Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
2. Patient who has previously received any prior therapy for lymphoma
3. Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
4. Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
Other protocol-defined exclusion criteria will apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method