Health Condition 1: null- Advanced Follicular Lymphoma
Conditions
Interventions
Intervention1: â?¢Biological: CT-P10
Other Name: rituximab: â?¢Experimental: CT-P10 will be administrated upto maximum of 8 cycles during the Core Study Period with CVP(cyclophosphamide, vincristine,
Sponsors
CELLTRION Inc
PPD Pharmaceutical Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics â?¢AUCtau: Area under the serum concentration-time curve at steady state â?¢CmaxSS: Maximum serum concentration at steady stateTimepoint: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Overall Response rate - CR plus CRU plus PR â?¢CR: complete response â?¢CRu: unconfirmed complete response â?¢PR: partial responseTimepoint: Week 24 | — |
Countries
Belarus, Brazil, Bulgaria, Chile, Georgia, Greece, India, Italy, Mexico, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine
Contacts
Public ContactArun Sundriyal
PPD Pharmaceutical Development India Pvt. Ltd
Outcome results
None listed