Trial Outcomes & Findings for BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma (NCT NCT02417129)

Last Updated: 2017-01-30

Results Overview

The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL). The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment. Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

From first administration of study medication until 30 weeks thereafter.

Results posted on

2017-01-30

Participant Flow

It was planned to randomize approximately 250 patients (125 in each treatment group). Actually two patients were randomized, an additional patient was enrolled but not randomized. Two patients were randomised to BI 695500, thus no patient was treated with rituximab in this trial.

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 695500 Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.	Rituximab (US-licensed Rituxan) Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 695500 n=2 Participants Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
Age, Continuous	45.5 Years STANDARD_DEVIATION 3.54 • n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first administration of study medication until 30 weeks thereafter.

Population: As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.

Outcome measures

Outcome measures
Measure	BI 695500 n=2 Participants Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.	Rituximab (US-licensed Rituxan) Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab CR	0 participants	—
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab PR	1 participants	—

SECONDARY outcome

Timeframe: Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204

Population: As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.

Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 204 or end of study

Population: Safety Analysis Set (SAF). As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.

Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30. This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial.

Outcome measures

Outcome measures
Measure	BI 695500 n=2 Participants Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.	Rituximab (US-licensed Rituxan) Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
Immunogenicity at Week 30	0 participants	—

Adverse Events

BI 695500

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Rituximab (US-licensed Rituxan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BI 695500 n=2 participants at risk Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.	Rituximab (US-licensed Rituxan) Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
Gastrointestinal disorders Constipation	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Gastrointestinal disorders Nausea	100.0% 2/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
General disorders Fatigue	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
General disorders Feeling cold	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Infections and infestations Nasopharyngitis	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Infections and infestations Urinary tract infection	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Injury, poisoning and procedural complications Infusion related reaction	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Musculoskeletal and connective tissue disorders Neck pain	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Nervous system disorders Headache	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Nervous system disorders Paraesthesia	50.0% 1/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.
Skin and subcutaneous tissue disorders Rash	100.0% 2/2 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.	— 0/0 • From the first administration of study medication until 26 weeks after the last administration of study medication up to 204 days.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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