Neoplasms

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Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

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Follicular Lymphoma

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Rituximab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immunologic Factors

375 mg/m2; One intravenous infusion once a week for 4 weeks

BI 695500

Boehringer Ingelheim

This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

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

A Phase III, Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate Efficacy and Safety of BI 695500 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

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.

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.

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.

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.

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.

Rituximab (US-licensed Rituxan)

Age, Continuous

Gender

The randomized set (RS) includes all subjects who were randomized to a treatment.

No patient was randomized to rituximab.

As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed and safety data are therefore presented in this abbreviated Clinical Trial Report.

Boehringer Ingelheim, Call Center

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

Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab

Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)

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 at Week 30

Overall Study

BI695500, once a week for 4 weeks (4 administrations in total)

MabThera, once a week for 4 weeks (4 administration in total)

MabThera, once a week for 4 weeks (4 administrations in total)

MabThera

The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma

A Randomized, Double-blind, Parallel-arm, Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab (MabThera) Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

This outcome measure presents area under the concentration time curve of BI 695500 and Rituximab (MabThera®) over the first dosing interval (pre-infusion on Day 1 to pre-infusion on Day 8) (AUCDay 1-Day 8) for assessment of PK (Pharmacokinetics) similarity.

This outcome measure presents area under the concentration of BI 695500 and Rituximab (MabThera®) over the fourth dosing interval (pre-infusion on Day 22 to Day 29).

This outcome measure presents maximum measured concentration of BI 695500 and Rituximab (MabThera®) in plasma (Cmax) following Dose 1

This outcome measure presents maximum measured concentration of Rituximab (MabThera®) and BI 695500 in plasma (Cmax) following Dose 4.

This outcome measure presents area under the depletion-time curve of the CD19+ B-cell count (% change from baseline) in peripheral blood from pre-infusion on Day 1 until last measurement on Day 8 (pre-infusion) (AUC Day 1-Day 8, CD19+).

This outcome measure presents percent change from baseline of CD19+ B-cells in peripheral blood, measured after 7 days (i.e., Day 8 pre-infusion time point) (PCFBpre,2 CD19+).

Overall Response Rate (ORR) comprised Complete Response (CR) plus Partial Response (PR) evaluated approximately one month after last dose of BI 695500 or Rituximab \[MabThera®\]. Overall Response as defined by the revised International Working Group (IWG) Criteria 2007, using the Investigator's assessment.

This outcome measure presents percentage of patients with Treatment Emergent Adverse Events (TEAEs) selected for comparability assessment of BI 695500 and Rituximab (MabThera®).

The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.

The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.

Rituximab (MabThera®)

Total

Sex: Female, Male

Safety Analysis Set (SAS): The patients who received at least one dose of trial medication and classified as per treatment received.

Boehringer Ingelheim Call Center

The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had an estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).

Area Under the Concentration (AUC) Time Curve of BI 695500 and Rituximab (MabThera®) Over the First Dosing Interval (Pre-infusion on Day 1 to Pre-infusion on Day 8)

The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).

AUC of BI 695500 and Rituximab (MabThera®) Over the Fourth Dosing Interval (Pre-infusion on Day 22 to Day 29) (AUC Day 22-Day 29)

Maximum Measured Concentration of BI 695500 and Rituximab (MabThera®) in Plasma (Cmax) Following Dose 1

Maximum Measured Concentration of Rituximab (MabThera®) and BI 695500 in Plasma (Cmax) Following Dose 4

The PK analysis Set Descriptive (PKSD) consisted of all randomized subjects who received at least one dose of trial medication BI 695500 or Rituximab \[MabThera®\], had at least one post-treatment PK concentration value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).

Area Under the Depletion-time Curve of the Cluster of Differentiation (CD)19+ B-cell Count (% Change From Baseline (CFB)) in Peripheral Blood From Pre-infusion on Day 1 Until Last Measurement on Day 8 (Pre-infusion)

Change From Baseline (%) of CD19+ B-cells in Peripheral Blood Measured After Seven Days on Day 8 (Day 8 Pre-infusion Time Point)

Overall Response Rate (ORR) (Complete Response (CR) Plus Partial Response (PR)) Evaluated Approximately One Month After Last Dose of BI 695500 or Rituximab (MabThera®)

Percentage of Patients With Treatment Emergent Adverse Events (TEAEs) Selected for Comparability Assessment of BI 695500 and Rituximab (MabThera®)

The subjects received BI 695500 (Test)/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.

The subjects received Rituximab (MabThera® (Reference))/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma	NCT02417129	Lymphoma, Non-H...	Rituximab BI 695500	18 Years - 99 Years	Boehringer Ingelheim
BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma	NCT02417129	Lymphoma, Non-H...	Rituximab BI 695500	18 Years - 99 Years	Boehringer Ingelheim
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma	NCT01950273	Lymphoma, Folli...	BI 695500 MabThera	18 Years -	Boehringer Ingelheim
BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma	NCT02417129	Lymphoma, Non-H...	Rituximab BI 695500	18 Years - 99 Years	Boehringer Ingelheim

Spots Global Cancer Trial Database for bi 695500

Every month we try and update this database with for bi 695500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bi 695500

Every month we try and update this database with for bi 695500 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bi 695500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.