A clinical trial to compare the effects of two drugs DRL_RI and MabThera® for treatment in subjects with low tumor burden of follicular lymphoma (cancer of the immune system), who were not treated earlier.
- Conditions
- Health Condition 1: C820- Follicular lymphoma grade IHealth Condition 2: C821- Follicular lymphoma grade IIHealth Condition 3: C823- Follicular lymphoma grade IIIa
- Registration Number
- CTRI/2019/05/019044
- Lead Sponsor
- Dr Reddys Laboratories SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
1)Subject is Male or female subjects aged greater than or equals to 18 years of age.
2)Subject is histologically confirmed, Grade 1-3a, previously untreated, CD20-positive.
3)Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
4)Subject has Low tumor burden follicular lymphoma as per Groupe dEtude des Lymphomes Folliculaires (GELF) Criteria
5)Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
a) Nodal lesion greater than 15 mm in the longest dimension; or
b) Nodal lesion >10 mm to less than or equals to 15 mm in the longest dimension and >10 mm in the shortest dimension
c) Extra-nodal lesion with both long and short dimensions greater than or equals to 10 mm.
6)Subject has Life expectancy greater than or equals to 3 months.
7)If female subject, then subject should be non pregnant, non lactating.
1)Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
2)Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
3)Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
4)Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
5)Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
6) Subjects with known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
Subjects with positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody can only be included in the study only if the criteria mentioned in the protocol are met.
7) Subjects who received a live vaccine within last 3 months of the first administration of study drug except vaccine against COVID-19.
8)Subjects with history or presence of a medical condition or disease that in the Investigators opinion would place the subject at an unacceptable risk for study participation.
9)Participation in any clinical study or having taken any investigational therapy (within 2 months of the first dose of study drug).
10)Women of childbearing potential who do not consent to use highly effective methods of birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method