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

Lymphoma, Non-Hodgkin Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02417129
• Other study ID #: 1301.6
• Secondary ID: 2014-004544-36
• Status: Terminated
• Phase: Phase 3
• First received: April 10, 2015
• Last updated: August 4, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina:Australia:Austria: Federal Ministry for Health Family and YouthBelgium:Brazil:Bulgaria:Chile:Colombia:Croatia:Czech Republic:Egypt:France:Germany:India:Korea, Republic of:Malaysia:Mexico:New Zealand:Peru:Portugal:South Africa:Spain:Sri Lanka:Thailand:Turkey:Ukraine:United States: Food and Drug AdministrationVietnam:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Rituximab
BI 695500 375 mg/M2
• BI 695500
BI 695500 375 mg/M2

Locations

Country	Name	City	State
Austria	1301.6.6601 Boehringer Ingelheim Investigational Site	Graz
Belgium	1301.6.0308 Boehringer Ingelheim Investigational Site	Leuven
Belgium	1301.6.0302 Boehringer Ingelheim Investigational Site	Namur
Bulgaria	1301.6.0614 Boehringer Ingelheim Investigational Site	Plovdiv
Bulgaria	1301.6.0612 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1301.6.0616 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1301.6.0618 Boehringer Ingelheim Investigational Site	Sofia
Croatia	1301.6.1002 Boehringer Ingelheim Investigational Site	Zagreb
Croatia	1301.6.1006 Boehringer Ingelheim Investigational Site	Zagreb
Croatia	1301.6.1008 Boehringer Ingelheim Investigational Site	Zagreb
Czech Republic	1301.6.1104 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1301.6.1108 Boehringer Ingelheim Investigational Site	Praha
United States	1301.6.5552 Boehringer Ingelheim Investigational Site	Albany	Georgia
United States	1301.6.5722 Boehringer Ingelheim Investigational Site	Bakersfield	California
United States	1301.6.5704 Boehringer Ingelheim Investigational Site	Burbank	California
United States	1301.6.5706 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	1301.6.5702 Boehringer Ingelheim Investigational Site	East Setauket	New York
United States	1301.6.5716 Boehringer Ingelheim Investigational Site	Fayetteville	North Carolina
United States	1301.6.5724 Boehringer Ingelheim Investigational Site	Loma Linda	California
United States	1301.6.5710 Boehringer Ingelheim Investigational Site	Middletown	Ohio
United States	1301.6.5714 Boehringer Ingelheim Investigational Site	Morristown	New Jersey
United States	1301.6.5726 Boehringer Ingelheim Investigational Site	Muscle Shoals	Alabama
United States	1301.6.5720 Boehringer Ingelheim Investigational Site	Northbrook	Illinois
United States	1301.6.5532 Boehringer Ingelheim Investigational Site	Ogden	Utah
United States	1301.6.5708 Boehringer Ingelheim Investigational Site	Pittsfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Croatia,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response (measured as Overall Response Rate {ORR}), which is Completed Response (CR) + Partial Response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by IWG criteria		30 weeks	No
Secondary	Extraporated AUC 0-T, SS establised by PPK from plasma concentrations of BI 695500 or rituximab sampled during the trial period		30 weeks	No
Secondary	Immunogenicity at Week 30		30 weeks	No

External Links

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