Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants

RIM - Rituximab in Maintenance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02536664

Enrollment

505

Registered

2015-09-01

Start date

2009-09-30

Completion date

2014-06-30

Last updated

2023-04-18

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

Conditions

Follicular Lymphoma

Brief summary

It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.

Interventions

DRUGRituximab

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age over 18 years * Previously untreated, relapsed or refractory CD 20-positive FL * Responding to rituximab containing induction therapy (complete response \[CR\] or partial response \[PR\]) * To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study) * No ineligibility for rituximab

Exclusion criteria

Not Applicable (NA)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Were Alive and Free From Progressive Disease	2 years	Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Were Alive	2 years	Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.
Median Overall Survival (OS) Time	2 years	Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.
Median Progression Free Survival (PFS) Time	2 years	PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.
Percentage of Participants With Best Overall Response	2 years	The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Percentage of Participants With Initiation of New Therapy	2 years	Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy	2 years	CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.

Countries

Germany

Participant flow

Pre-assignment details

Fifteen out of 505 participants were screen failure and excluded from the baseline and safety data sets. Safety Set Overall (SSO) included 490 participants who received at least 1 dose of study drug in/during the maintenance period. Therapy line was not reported for 1 participant and participant flow was reported for 489 participants.

Participants by arm

Arm	Count
First-line Stratum Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.	310
Relapsed/Refractory Stratum Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.	173
Total	483

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death due to lymphoma	2	1
Overall Study	Death due to other reason	3	2
Overall Study	Inadequate completion of documentation	2	4
Overall Study	Intolerability	8	6
Overall Study	Missing	53	20
Overall Study	Other	18	24
Overall Study	Progression	13	18
Overall Study	Withdrawal by Subject	8	5

Baseline characteristics

Characteristic	First-line Stratum	Relapsed/Refractory Stratum	Total
Age, Continuous	62.7 years STANDARD_DEVIATION 11.6	64.0 years STANDARD_DEVIATION 11	63.1 years STANDARD_DEVIATION 11.4
Sex: Female, Male Female	171 Participants	94 Participants	265 Participants
Sex: Female, Male Male	139 Participants	79 Participants	218 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 310	30 / 173
serious Total, serious adverse events	35 / 312	39 / 177

Outcome results

Primary

Percentage of Participants Who Were Alive and Free From Progressive Disease

Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.

Time frame: 2 years