Trial Outcomes & Findings for A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma (NCT NCT02569996)

Last Updated: 2015-12-10

Results Overview

Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

124 participants

Primary outcome timeframe

From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years

Results posted on

2015-12-10

Participant Flow

This study was conducted between 08 July 2005 to 12 Aug 2013 at 15 sites in Hungary.

A total number of 124 patients were recruited. Of these, 83 patients completed the maintenance therapy with rituximab (MabThera) and entered the 3-year follow-up phase. Of these, 69 patients completed the follow-up phase.

Participant milestones

Participant milestones
Measure	Rituximab Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Overall Study STARTED	124
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Overall Study Adverse Event	6
Overall Study Physician Decision	3
Overall Study Progression of the disease	18
Overall Study New anti-lymphoma treatment	1
Overall Study Non-compliance	9
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	5
Overall Study Complete remission	7
Overall Study Unknown reason	1

Baseline Characteristics

A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years

Population: ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.

Outcome measures

Outcome measures
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Event-free Survival	53.944 months Interval 50.242 to 57.647

SECONDARY outcome

Timeframe: Up to 27 months

Population: Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug.

An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death

Outcome measures

Outcome measures
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Number of Participants With Adverse Events (AEs) SAEs	14 participants
Number of Participants With Adverse Events (AEs) Non serious AEs	32 participants

SECONDARY outcome

Timeframe: From randomization until death, assessed up to 5 years

Population: ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.

Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

Outcome measures

Outcome measures
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Overall Survival (OS)	72.959 months Interval 70.303 to 75.616

SECONDARY outcome

Timeframe: From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years

Population: ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.

Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

Outcome measures

Outcome measures
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Time to Progression (TTP)	56.024 months Interval 52.532 to 59.516

SECONDARY outcome

Timeframe: From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years

Population: ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.

Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

Outcome measures

Outcome measures
Measure	Rituximab n=124 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Time to Next Anti-lymphoma Treatment (TTNLT)	59.236 months Interval 56.318 to 62.153

SECONDARY outcome

Timeframe: From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years

Population: ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis

Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

Outcome measures

Outcome measures
Measure	Rituximab n=122 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Duration of Response (DR)	63.159 months Interval 59.29 to 67.029

SECONDARY outcome

Timeframe: From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years

Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

Outcome measures

Outcome measures
Measure	Rituximab n=77 Participants Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Disease-free Survival (DFS)	66.737 months Interval 63.808 to 69.666

Adverse Events

Rituximab

Serious events: 14 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab n=124 participants at risk Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Blood and lymphatic system disorders Neutropenia	0.81% 1/124 • Up to 27 months
Blood and lymphatic system disorders Agranulocytosis	0.81% 1/124 • Up to 27 months
Blood and lymphatic system disorders Febrile neutropenia	0.81% 1/124 • Up to 27 months
Gastrointestinal disorders Abdominal discomfort	0.81% 1/124 • Up to 27 months
Gastrointestinal disorders Diarrhoea	0.81% 1/124 • Up to 27 months
Gastrointestinal disorders Gastric ulcer	0.81% 1/124 • Up to 27 months
Gastrointestinal disorders Oral disorder	0.81% 1/124 • Up to 27 months
General disorders Oedema	0.81% 1/124 • Up to 27 months
Infections and infestations Acute hepatitis B	0.81% 1/124 • Up to 27 months
Infections and infestations Erysipelas	0.81% 1/124 • Up to 27 months
Infections and infestations Hepatitis B	0.81% 1/124 • Up to 27 months
Infections and infestations Nasopharyngitis	0.81% 1/124 • Up to 27 months
Infections and infestations Otitis media	0.81% 1/124 • Up to 27 months
Infections and infestations Strongyloidiasis	0.81% 1/124 • Up to 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the gastrointestinal tract	0.81% 1/124 • Up to 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.81% 1/124 • Up to 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.81% 1/124 • Up to 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.81% 1/124 • Up to 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.81% 1/124 • Up to 27 months
Nervous system disorders Generalised tonic-clonic seizure	0.81% 1/124 • Up to 27 months
Nervous system disorders Vascular encephalopathy	0.81% 1/124 • Up to 27 months
Psychiatric disorders Confusional state	0.81% 1/124 • Up to 27 months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.81% 1/124 • Up to 27 months
Respiratory, thoracic and mediastinal disorders Pneumonia	1.6% 2/124 • Up to 27 months

Other adverse events

Other adverse events
Measure	Rituximab n=124 participants at risk Participants received rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months
Endocrine disorders Diabetes mellitus	2.4% 3/124 • Up to 27 months

Additional Information

F. Hoffmann-La Roche AG

Roche Trial Information Hotline

Phone: +41 61 6878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place