A study of GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (a type of cancer)

Phase 3

Active, not recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2012/04/002587
• Lead Sponsor: Hexal AG

Brief Summary

The purpose of this clinical study is to demonstrate comparability between the biosimilar agent GP2013 and MabThera**®** (which in some countries also marketed under the name Rituxan®)

Note: The inadvertant/system error in tab "Recruitment Status of Trial" led to change in enrollment status on 24 Jan 2013. The error was corrected on 15 Feb 2013. The recruitment status is "Open to Recruitment".

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-13
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 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
Overall response rate in patients with Follicular Lymphoma	Time Frame - 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with Adverse Events (AEs)	Time Frame - upto 2 years

Trial Locations

Locations (34)

Apollo Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apollo Speciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Bhagwan Mahaveer Cancer Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Bharat Cancer Hospital & Research Institute; 🇮🇳 Surat, GUJARAT, India

Central India Cancer Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Centre for Stem Cell Research, Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Deenanath Mangeshkar Hospital (DMH) & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Fortis Healthcare; 🇮🇳 Amritsar, PUNJAB, India

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Apollo Hospitals

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr S V S S Prasad

Principal investigator

919848018804

hydaherf@gmail.com