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Monoclonal Antibodies

DRL_RI (Proposed rituximab biosimilar) for Follicular Lymphoma (FLINTER Trial)

Phase 3
Waitlist Available
Research Sponsored by Dr. Reddy's Laboratories Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 7 (week 28)
Awards & highlights

FLINTER Trial Summary

This trial will compare the safety and efficacy of two treatments for people with a certain type of cancer. The goal is to show that one treatment is just as effective as the other.

Eligible Conditions
  • Follicular Lymphoma

FLINTER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 7 (week 28)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 7 (week 28) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma
Secondary outcome measures
Complete Response Rate
Complete Response Rate as a Best Response
Duration of Response (DOR)
+5 more
Other outcome measures
Exploratory- to explore the PK parameters of DRL_RI and MabThera®, using a population-PK modelling approach
Exploratory- to explore the pharmacodynamic parameters of DRL_RI and MabThera
Exploratory-To compare ORR evaluated in accordance with the Lugano criteria

Side effects data

From 2023 Phase 3 trial • 317 Patients • NCT03976102
12%
COVID-19
8%
Neutropenia
7%
Pruritus
6%
COVID-19 pneumonia
4%
Nausea
2%
Abdominal pain
1%
Anal abscess
1%
Haematoma muscle
1%
Otitis externa
1%
Influenza
1%
Angina unstable
1%
Chronic obstructive pulmonary disease
1%
Infusion-related reaction
1%
Pyrexia
1%
Syncope
1%
Facial paralysis
1%
Appendicitis
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: DRL_RI
Arm B: MabThera®

FLINTER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: DRL_RIExperimental Treatment1 Intervention
DRL_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
Group II: Arm B: MabThera®Active Control1 Intervention
MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DRL_RI (Proposed rituximab biosimilar)
2019
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

Dr. Reddy's Laboratories LimitedLead Sponsor
234 Previous Clinical Trials
22,912 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,509 Total Patients Enrolled
Carina Flemmig, MDStudy DirectorParexel

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does DRL_RI (Proposed rituximab biosimilar) have any harmful side effects?

"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, which suggests that DRL_RI (Proposed rituximab biosimilar) is safe."

Answered by AI

What is the purpose of this research?

"The main objective of this clinical trial is to assess the Overall Response Rate (ORR) for follicular lymphoma over a period of approximately 7 months (Week 28). Secondary objectives include safety in terms of Adverse Events, overall survival, and tolerability. Data will be compared between the groups receiving the different treatments."

Answered by AI

In how many distinct places is this particular clinical trial being conducted?

"There are 6 clinical trial sites enrolling patients for this study, which include locations in Houston, Whittier and Knoxville. If you're interested in participating, try to select a centre close to your home to minimize travel difficulties."

Answered by AI

How many people fit the specified criteria for this research project?

"Unfortunately, this particular trial is no longer recruiting patients. Although, if you are interested in similar studies, there are currently 1758 trials for lymphoma and 420 trials for DRL_RI (Proposed rituximab biosimilar) that may have open spots."

Answered by AI

Are there other published scientific papers involving DRL_RI (Proposed rituximab biosimilar)?

"DRL_RI was initially studied in 1993 at the National Institutes of Health Clinical Center. So far, there have been 802 completed clinical trials with 420 more recruiting patients as we speak. A large number of these active trials are based out of Houston, Texas."

Answered by AI

Are volunteers currently being sought for this research?

"Unfortunately, this study isn't enrolling patients right now. It was originally posted on February 1st, 2019 and was last updated on May 27th, 2022. However, there are presently 1758 clinical trials actively searching for patients with lymphoma and 420 trials for DRL_RI (Proposed rituximab biosimilar) that are also looking for participants."

Answered by AI

For what purpose is DRL_RI (Proposed rituximab biosimilar) most often given to patients?

"The drug DRL_RI (Proposed rituximab biosimilar) is used to treat diffuse large b-cell lymphoma (dlbcl), but it can also be effective against other conditions like b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
2019. "Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03976102.
~54 spots leftby Apr 2025
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