MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430352

Enrollment

545

Registered

2007-02-01

Start date

2006-09-04

Completion date

2011-05-26

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Brief summary

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Interventions

DRUGrituximab [MabThera/Rituxan]

375mg/m2 iv every 8 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients, \>=18 years of age; * histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma; * patients who have received adequate (\>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease; * demonstrated partial or complete response to induction therapy.

Exclusion criteria

* stable or progressive disease after most recent induction therapy; * transformation to high grade lymphoma; * patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With an Adverse Event (AE) - Overall Summary	24 months	Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.

Secondary

Measure	Time frame	Description
Progression-Free Survival - Time to Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Event-Free Survival (EFS) - Percentage of Participants With an Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Event-Free Survival (EFS) - Time to Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Overall Survival (OS) - Percentage of Participants With an Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Progression-Free Survival - Percentage of Participants With an Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time to NLT - Time to Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Percentage of Participants With Response by Best Response to Study Treatment	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Percentage of Participants With PR Who Converted to CRu	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.
Overall Survival (OS) - Time to Event	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose	OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.

Countries

Albania, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Colombia, Croatia, Ecuador, Egypt, Finland, Germany, Greece, Israel, Italy, Mexico, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye)

Participant flow

Participants by arm

Arm	Count
Rituximab 375 mg/m^2 Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.	545
Total	545

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	16
Overall Study	Death	5
Overall Study	Disease progression	58
Overall Study	Other	48
Overall Study	Withdrawal by Subject	11

Baseline characteristics

Characteristic	Rituximab 375 mg/m^2
Age, Continuous	56.3 years STANDARD_DEVIATION 11.47
Sex: Female, Male Female	313 Participants
Sex: Female, Male Male	232 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	207 / 534
serious Total, serious adverse events	109 / 534

Outcome results

Primary

Percentage of Participants With an Adverse Event (AE) - Overall Summary

Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.

Time frame: 24 months

Population: Safety Population: any participant who received at least 1 dose of study treatment.

Arm	Measure	Group	Value (NUMBER)
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Any AE	67.4 percentage of participants
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Any infusion-related AE	5.8 percentage of participants
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Any non-infusion related SAE	20.2 percentage of participants
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Any infusion-related SAE	0.2 percentage of participants
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Deaths	7.5 percentage of participants
Rituximab 375 mg/m^2	Percentage of Participants With an Adverse Event (AE) - Overall Summary	Toxicity as primary cause for discontinuation	3.0 percentage of participants

Secondary

Event-Free Survival (EFS) - Percentage of Participants With an Event

The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.