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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02417129
• Date of registration: 10/04/2015
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
• Scientific title: 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
• Date of first enrolment: April 2015
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02417129
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Colombia, Croatia, Czech Republic, Egypt, France, Germany, India, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, South Africa, Spain, Sri Lanka, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

1. Written informed consent that is consistent with ICH GCP guidelines and local
legislations.

2. Male or female patients, at least 18 years of age at Screening.

3. Histologically-confirmed, stage II - IV NHL (CD20+ FL of Grades 1, 2, or 3a).

4. Low tumor burden according to the GELF criteria

5. 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.

6. Patients not previously treated for their FL, including any previous treatment for FL
under clinical trials.

7. ECOG performance status of 0 to 1.

8. 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

9. Adequate hematological function (unless abnormalities are related to lymphoma
infiltration of the bone marrow) within 28 days prior to randomization

10. Adequate renal and liver function:

11. For participants of reproductive potential (males and females), use of a medically
acceptable method of contraception during the trial

Exclusion criteria:

1. Transformation to high-grade lymphoma (secondary to low-grade lymphoma) prior to study
entry.

2. Circulating tumor cells = 5 × 109/L.

3. Presence or history of central nervous system lymphoma.

4. Patients receiving current treatment with corticosteroids must not be receiving a dose
exceeding 20 mg/day prednisone or equivalent.

5. Patients with prior or concomitant malignancies within 5 years prior to Screening

6. Major surgery within 28 days prior to randomization.

7. 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.

8. 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.

9. Serious underlying medical conditions, that, per the Investigator¿s discretion, could
impair the ability of the patient to participate in the trial.

10. Known hypersensitivity or allergy to murine products.

11. History of a severe allergic reaction or anaphylactic reaction to a biological agent
or history of hypersensitivity to any component of the trial medication.

12. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.

13. Prior treatment with BI 695500 and/or rituximab.

14. 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.

15. 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.

16. Any other co-existing medical or psychological condition(s) that will preclude
participation in the trial or compromise ability to give informed consent and/or
comply with study procedures.

17. Pregnancy or breast feeding. For women of childbearing potential, a positive serum
pregnancy test at the Screening Visit.

18. Patients who have significant cardiac disease, including but not limited to congestive
heart failure of Class III or IV of the NYHA classification; uncontrolled angina or
arrhythmia; any uncontrolled or severe cardiovascular or cerebrovascular disease; or
uncontrolled hypertension.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma, Non-Hodgkin

Intervention(s)

Drug: Rituximab

Drug: BI 695500

Primary Outcome(s)

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

Secondary Outcome(s)

Immunogenicity at Week 30 [Time Frame: Day 204 or end of study]

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-t, ss) [Time Frame: 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]

Secondary ID(s)

1301.6

2014-004544-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02417129