Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Completed · Phase 3
Conditions studied: Follicular Lymphoma
In brief
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity. The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Key facts
- Study ID
- NCT03976102
- Run by
- Dr. Reddy's Laboratories Limited
- People needed
- 317
- Starts
- 2019-05-15
- Expected to finish
- 2023-02-27
- Last updated by the study team
- 2024-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is Male or female subjects aged ≥18 years of age.
- Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.
- Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
- Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria
- Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
- Nodal lesion >15 mm in the longest dimension; or
- Noda l lesion >10 mm to he longest dimension; dimens ion and >10 mm in the shortest dimension; or
- Extra-nodal lesion with both long and short dimensions ≥10 mm.
- Subject has Life expectancy ≥3 months.
- If female subject, then subject should be non-pregnant, non-lactating.
You may not qualify if…
- Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
- Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
- Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
- Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
- Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
- Subjects with known sero-positivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) will be excluded. And if positive for hepatitis B core antibody or hepatitis C virus (HCV) antibody can only be enrolled if HBV - DNA level <20 IU/mL (or 112 copies/mL) and HCV - RNA is negative respectively by PCR test..
- Subjects who have received a live vaccine within last 3 months of the first administration of study drug.
- Subjects with history or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk for study participation.
- Participation in any clinical study or having taken any investigational therapy (within 2-months of the first dose of study drug.
- Women of childbearing potential who do not consent to use highly effective methods of birth control.
Where it is running
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
- American Oncology Partners of Maryland — Bethesda, Maryland, United States
- University of Tennessee Medical Center - Cancer Institute — Knoxville, Tennessee, United States
- Gulf coast Oncology Associates, PA — Houston, Texas, United States
Full record on ClinicalTrials.gov
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