Trial · NCT01419665

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

NCT01419665, Phase 3, Completed, Sandoz; results first posted 2021-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL). Trials, record NCT01419665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01419665

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
NCT number: NCT01419665
Status: Completed
Phases: Phase 3
Enrollment: 629 participants, actual
Lead sponsor: Sandoz
Conditions: Follicular Lymphoma
Interventions: GP2013, rituximab
First posted: 2011-08-18
Last updated: 2021-05-14
Other registries' IDs: eudract:2010-019522-13
Results first posted: 2021-05-14

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR)	24 weeks	ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Secondary	To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period	24 weeks
Secondary	To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period	24 weeks
Secondary	To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	3 years	Number of participants with progression free survival events
Secondary	To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	3 years	OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
Secondary	To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)	24 weeks, 3 years	number of participants with confirmed positive ADA
Secondary	To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)	day 63	C max For descriptive purposes only, no hypothesis testing
Secondary	To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)	day 63	C through For descriptive purposes only, no hypothesis testing
Secondary	To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy	21 days	AUEC (0-21d) For descriptive purposes only, no hypothesis testing

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate (ORR)	24 weeks	per protocol set, participants with measure	percentage	NUMBER
SECONDARY	To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period	24 weeks	per protocol set, participants with measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period	24 weeks	per protocol set, participants with measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	3 years	per protocol set, participants with measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	3 years	per protocol set, participants with measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)	24 weeks, 3 years	immunogenicity set, participants with measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)	day 63	pharmacokinetic analysis set 1, participants with measure	microg/mL	GEOMETRIC_MEAN
SECONDARY	To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)	day 63	pharmacokinetic analysis set 1, participants with measure	microg/mL	MEAN
SECONDARY	To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy	21 days	Pharmnacodynamic analysis set, participants with measure	%*day	GEOMETRIC_MEAN
POST_HOC	All Collected Deaths	30 months, 3 years	clinical data base population - treated patients	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Response Rate (ORR)	GP2013	87.1	90% Confidence Interval 83.59 to 90.15	percentage
Overall Response Rate (ORR)	Rituximab	87.5	90% Confidence Interval 84.04 to 90.49	percentage
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period	GP2013	46		Participants
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period	Rituximab	42		Participants
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period	GP2013	225		Participants
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period	Rituximab	232		Participants
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	GP2013	97		Participants
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	Rituximab	78		Participants
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	GP2013	29		Participants
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	Rituximab	31		Participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Combination Treatment	STARTED	GP2013	312
Combination Treatment	STARTED	Rituximab	315
Combination Treatment	COMPLETED	GP2013	274
Combination Treatment	COMPLETED	Rituximab	274
Combination Treatment	NOT COMPLETED	GP2013	38
Combination Treatment	NOT COMPLETED	Rituximab	41
Maintenance Treatment and/or Follow up	STARTED	GP2013	254
Maintenance Treatment and/or Follow up	STARTED	Rituximab	252
Maintenance Treatment and/or Follow up	COMPLETED	GP2013	132
Maintenance Treatment and/or Follow up	COMPLETED	Rituximab	150

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events892

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
other	Anaemia	Blood and lymphatic system disorders	Combination GP2013+CVP	25	312
other	Anaemia	Blood and lymphatic system disorders	Combination MabThera+CVP	28	315
other	Anaemia	Blood and lymphatic system disorders	Maintenance GP2013	2	254
other	Anaemia	Blood and lymphatic system disorders	Maintenance MabThera	5	252
other	Leukopenia	Blood and lymphatic system disorders	Combination GP2013+CVP	23	312
other	Leukopenia	Blood and lymphatic system disorders	Combination MabThera+CVP	25	315
other	Leukopenia	Blood and lymphatic system disorders	Maintenance GP2013	11	254
other	Leukopenia	Blood and lymphatic system disorders	Maintenance MabThera	5	252
other	Neutropenia	Blood and lymphatic system disorders	Combination GP2013+CVP	78	312
other	Neutropenia	Blood and lymphatic system disorders	Combination MabThera+CVP	91	315

1 to 10 of 892Source ClinicalTrials.gov

See all 892 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combination GP2013+CVP	4	312
Total, all-cause mortality	Combination MabThera+CVP	5	315
Total, all-cause mortality	Maintenance GP2013	2	254
Total, all-cause mortality	Maintenance MabThera	2	252
Total, other adverse events	Combination GP2013+CVP	262	312
Total, other adverse events	Combination MabThera+CVP	255	315
Total, other adverse events	Maintenance GP2013	141	254
Total, other adverse events	Maintenance MabThera	144	252
Total, serious adverse events	Combination GP2013+CVP	71	312
Total, serious adverse events	Combination MabThera+CVP	63	315

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28712941	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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GP2013 vs Rituximab: To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	Trial comparisons
GP2013 vs Rituximab: To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period	Trial comparisons
GP2013 vs Rituximab: To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period	Trial comparisons
GP2013 vs Rituximab: To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01419665

GET https://conductscience.org/api/trials/v1/NCT01419665/results?page=2

API reference For AI assistants