Trial · NCT03976102
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
NCT03976102, Phase 3, Completed, Dr. Reddy's Laboratories Limited, India; results first posted 2024-01-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma. Trials, record NCT03976102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03976102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
- NCT number
- NCT03976102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 317 participants, actual
- Lead sponsor
- Dr. Reddy's Laboratories Limited, India
- Conditions
- Follicular Lymphoma
- Interventions
- DRL_RI (Proposed rituximab biosimilar), MabThera®
- First posted
- 2019-06-05
- Last updated
- 2024-01-22
- Results first posted
- 2024-01-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Month 7 (Week 28) | Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR. |
| Secondary | Overall Response Rate (ORR) | Week 12, Week 28 | The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR. |
| Secondary | Complete Response Rate | Week 28 | Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. |
| Secondary | Complete Response Rate as a Best Response | Week 28 | Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. |
| Secondary | Duration of Response (DOR) | Week 52 | Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \[LDi\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. |
| Secondary | Progression-free Survival (PFS) | Week 52 | Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. |
| Secondary | Overall Survival (OS) | Week 52 | The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS. |
| Secondary | Number of Participants With Adverse Events | From Screening (Day -28 to -1) up to 52 weeks | The safety and tolerability of DRL\_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated. |
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) | On Day 1, Week 2, Week 3, Week 4, Week 12 post dose | The immunogenicity of the Proposed Rituximab Biosimilar (DRL\_RI) with MabThera® among trial participants was compared. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Month 7 (Week 28) | The ITT Analysis Set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Week 12, Week 28 | The ITT Analysis Set included all randomized participants. | percentage of particpants | NUMBER |
| SECONDARY | Complete Response Rate | Week 28 | The ITT Analysis Set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate as a Best Response | Week 28 | The ITT Analysis Set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Week 52 | The ITT Analysis Set included all randomized participants. The number analyzed are the participants with complete response, unconfirmed complete response or partial response. | Weeks | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Week 52 | The ITT Analysis Set included all randomized participants. | Weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Week 52 | The ITT Analysis Set included all randomized participants. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | From Screening (Day -28 to -1) up to 52 weeks | The Safety Analysis Set (SAF) will include all the participants who have received at least one dose of study drug. The SAF will be used for safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Anti-drug Antibody (ADA) | On Day 1, Week 2, Week 3, Week 4, Week 12 post dose | The ITT Analysis Set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Arm A: DRL_RI | 80.2 | 95% Confidence Interval 73.3 to 86.1 | percentage of participants | |
| Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Arm B: MabThera® | 79.4 | 95% Confidence Interval 72.1 to 85.4 | percentage of participants | |
| Overall Response Rate (ORR) | Arm A: DRL_RI | Week 12 | 62.3 | 95% Confidence Interval 54.4 to 69.8 | percentage of particpants |
| Overall Response Rate (ORR) | Arm B: MabThera® | Week 12 | 63.9 | 95% Confidence Interval 55.8 to 71.4 | percentage of particpants |
| Overall Response Rate (ORR) | Arm A: DRL_RI | Week 28 | 75.3 | 95% Confidence Interval 67.9 to 81.7 | percentage of particpants |
| Overall Response Rate (ORR) | Arm B: MabThera® | Week 28 | 73.5 | 95% Confidence Interval 65.9 to 80.3 | percentage of particpants |
| Complete Response Rate | Arm A: DRL_RI | 32.7 | 95% Confidence Interval 25.6 to 40.5 | percentage of participants | |
| Complete Response Rate | Arm B: MabThera® | 34.2 | 95% Confidence Interval 26.8 to 42.2 | percentage of participants | |
| Complete Response Rate as a Best Response | Arm A: DRL_RI | 34.0 | 95% Confidence Interval 26.7 to 41.8 | percentage of participants | |
| Complete Response Rate as a Best Response | Arm B: MabThera® | 35.5 | 95% Confidence Interval 28.0 to 43.6 | percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: DRL_RI | 162 | |
| Overall Study | STARTED | Arm B: MabThera® | 155 | |
| Overall Study | COMPLETED | Arm A: DRL_RI | 143 | |
| Overall Study | COMPLETED | Arm B: MabThera® | 129 | |
| Overall Study | NOT COMPLETED | Arm A: DRL_RI | 19 | |
| Overall Study | NOT COMPLETED | Arm B: MabThera® | 26 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: DRL_RI | 13 | 162 | 14 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: MabThera® | 2 | 153 | 3 |
| other | Nausea | Gastrointestinal disorders | Arm A: DRL_RI | 6 | 162 | 8 |
| other | Nausea | Gastrointestinal disorders | Arm B: MabThera® | 10 | 153 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: DRL_RI | 3 | 162 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: MabThera® | 8 | 153 | 10 |
| other | Pyrexia | General disorders | Arm A: DRL_RI | 1 | 162 | 1 |
| other | Pyrexia | General disorders | Arm B: MabThera® | 10 | 153 | 10 |
| other | COVID-19 | Infections and infestations | Arm A: DRL_RI | 19 | 162 | 20 |
| other | COVID-19 | Infections and infestations | Arm B: MabThera® | 17 | 153 | 19 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: DRL_RI | 3 | 162 |
| Total, all-cause mortality | Arm B: MabThera® | 2 | 153 |
| Total, other adverse events | Arm A: DRL_RI | 47 | 162 |
| Total, other adverse events | Arm B: MabThera® | 49 | 153 |
| Total, serious adverse events | Arm A: DRL_RI | 22 | 162 |
| Total, serious adverse events | Arm B: MabThera® | 21 | 153 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40421128 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: DRL_RI vs Arm B: MabThera®: deaths from any cause | Trial comparisons |
| Arm A: DRL_RI vs Arm B: MabThera®: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03976102
GET https://conductscience.org/api/trials/v1/NCT03976102/results?page=2