To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan(Rituximab)in patients with advanced Follicular Lymphoma, a type of cancer.
- Conditions
- Health Condition 1: null- Advanced Follicular Lymphoma
- Registration Number
- CTRI/2014/11/005201
- Lead Sponsor
- CELLTRION Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria:
1.Patient is male or female older than 18 years.
2.Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
3.Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:
â?¦greater than 1.5 cm in the longest dimension or
â?¦between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis
4.Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
5.Patient has Ann Arbor stage III or IV disease.
1.Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
2.Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
3.Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
4.Patient has known central nervous system involvement.
5.Patient has received previous treatment for NHL:
â?¦Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
â?¦All doses of corticoid therapy for treatment of NHL
â?¦Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone 20 mg per day for the treatment for any purpose
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics <br/ ><br>â?¢AUCtau: Area under the serum concentration-time curve at steady state <br/ ><br>â?¢CmaxSS: Maximum serum concentration at steady stateTimepoint: week 12
- Secondary Outcome Measures
Name Time Method Efficacy <br/ ><br>Overall Response rate - CR plus CRU plus PR <br/ ><br>â?¢CR: complete response <br/ ><br>â?¢CRu: unconfirmed complete response <br/ ><br>â?¢PR: partial responseTimepoint: Week 24