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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417129
Recruitment Status : Terminated
First Posted : April 15, 2015
Results First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Rituximab Drug: BI 695500 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: BI 695500
375 mg/m2; One intravenous infusion once a week for 4 weeks
Drug: BI 695500
BI 695500 375 mg/M2

Active Comparator: Rituximab (US reference product)
375 mg/m2; One intravenous infusion once a week for 4 weeks
Drug: Rituximab
BI 695500 375 mg/M2




Primary Outcome Measures :
  1. 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. ]

    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.



Secondary Outcome Measures :
  1. 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) [ 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 ]
    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.

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

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417129


Locations
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United States, Alabama
Boehringer Ingelheim Investigational Site
Muscle Shoals, Alabama, United States
United States, California
Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
Boehringer Ingelheim Investigational Site
Burbank, California, United States
Boehringer Ingelheim Investigational Site
Loma Linda, California, United States
United States, Georgia
Boehringer Ingelheim Investigational Site
Albany, Georgia, United States
United States, Illinois
Boehringer Ingelheim Investigational Site
Northbrook, Illinois, United States
United States, Massachusetts
Boehringer Ingelheim Investigational Site
Pittsfield, Massachusetts, United States
United States, New Jersey
Boehringer Ingelheim Investigational Site
Morristown, New Jersey, United States
United States, New York
Boehringer Ingelheim Investigational Site
East Setauket, New York, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Fayetteville, North Carolina, United States
United States, Ohio
Boehringer Ingelheim Investigational Site
Middletown, Ohio, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Corpus Christi, Texas, United States
United States, Utah
Boehringer Ingelheim Investigational Site
Ogden, Utah, United States
Austria
Boehringer Ingelheim Investigational Site
Graz, Austria
Belgium
Boehringer Ingelheim Investigational Site
Leuven, Belgium
Boehringer Ingelheim Investigational Site
Namur, Belgium
Bulgaria
Boehringer Ingelheim Investigational Site
Plovdiv, Bulgaria
Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
Croatia
Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Czech Republic
Boehringer Ingelheim Investigational Site
Brno, Czech Republic
Boehringer Ingelheim Investigational Site
Praha, Czech Republic
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02417129    
Other Study ID Numbers: 1301.6
2014-004544-36 ( EudraCT Number: EudraCT )
First Posted: April 15, 2015    Key Record Dates
Results First Posted: January 30, 2017
Last Update Posted: January 30, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents