NCT02417129|TerminatedPhase 3Results

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

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1301.62014-004544-36

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredApr 2015

StartedApr 2015

CompletionDec 2015

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Apr 2015

Shorter than P25 for phase_3

Geographic Reach

6 countries

21 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

April 1, 2015

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2017

Completed

Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

April 10, 2015

Results QC Date

December 5, 2016

Last Update Submit

December 5, 2016

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab
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.
From first administration of study medication until 30 weeks thereafter.

Secondary Outcomes (2)

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)
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
Immunogenicity at Week 30
Day 204 or end of study

Study Arms (2)

BI 695500

EXPERIMENTAL

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

Drug: BI 695500

Rituximab (US reference product)

ACTIVE COMPARATOR

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

Drug: Rituximab

Interventions

RituximabDRUG

BI 695500 375 mg/M2

Rituximab (US reference product)

BI 695500DRUG

BI 695500 375 mg/M2

BI 695500

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent that is consistent with ICH GCP guidelines and local legislations.
Male or female patients, at least 18 years of age at Screening.
Histologically-confirmed, stage II - IV NHL (CD20+ FL of Grades 1, 2, or 3a).
Low tumor burden according to the GELF criteria
Diagnostic biopsies will be centrally reviewed by expert pathologists to confirm correct histology in accordance with WHO guidelines. If the interval since diagnosis is \> 12 months, a new biopsy will be required to confirm the histology remained unchanged.
Patients not previously treated for their FL, including any previous treatment for FL under clinical trials.
ECOG performance status of 0 to 1.
Have at least one measurable lesion as per the International Working Group (IWG) criteria 2007 at Screening (lesion clearly measurable in at least two perpendicular dimensions
Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization
Adequate renal and liver function:
For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial

You may not qualify if:

Transformation to high-grade lymphoma (secondary to low-grade lymphoma) prior to study entry.
Circulating tumor cells = 5 × 109/L.
Presence or history of central nervous system lymphoma.
Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent.
Patients with prior or concomitant malignancies within 5 years prior to Screening
Major surgery within 28 days prior to randomization.
Active, chronic or persistent infection that might worsen with immunosuppressive treatment; positive for HIV or tuberculosis (TB) at Screening. Patients who are confirmed positive and those who have active infections are excluded from the trial participation.
Patients with serological evidence of HBV infection. Patients seropositive because of HBV vaccine are eligible. HBV positive patients may participate following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated.
Serious underlying medical conditions, that, per the Investigator¿s discretion, could impair the ability of the patient to participate in the trial.
Known hypersensitivity or allergy to murine products.
History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial medication.
Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
Prior treatment with BI 695500 and/or rituximab.
Patients who received any prior therapy using mAbs will be excluded; this does not apply to other biological drugs such as growth factors or anticoagulants.
Treatment within a clinical trial within 4 weeks prior to initiation of trial treatment. Patients who have received treatment with a drug that has not received regulatory approval for any indication within 4 weeks or a minimum of 5 half-lives, whichever is longer, of the initial dose of trial medication.
+3 more criteria

Contact the study team to confirm eligibility.