Untreated stage III or IV non-Hodgkin’s lymphoma (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy) MedDRA version: 20.0 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 100000004851
Conditions
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, at least 18 years of age at Screening. - Untreated, histologically confirmed, stage III or IV NHL (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy). - Patients not previously treated. Eligible patients previously on watch and wait (i.e., those patients who do not require treatment upfront at the time of the diagnosis) can enter the trial. - ECOG performance status of 0 to 2. - Have at least one measurable lesion as per the IWG criteria 2007 at Screening. - Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization, including: • Hemoglobin = 9.0 g/dL (= 5.6 mmol/L). • Absolute neutrophil count = 1.5 x 109/L. • Platelet count = 100 x 109/L. - Adequate renal and liver function - For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: - Transformation to high-grade lymphoma (secondary to low grade lymphoma). - Presence or history of central nervous system (CNS) lymphoma. - Patients receiving current treatment with oral corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent. - Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, idarubicin and/or other anthracyclines and anthracenediones. - Patients with prior or concomitant malignancies. - Major surgery (excluding lymph node biopsy) within 28 days prior to randomization. - Poor renal function: serum creatinine > 2.0 mg/dL (> 197 mcmol/L). - Poor hepatic function: total bilirubin > 2.0 mg/dL (> 34 mcmol/L) or aspartate aminotransferase (AST) > 3 times the upper limit of normal. - Active, chronic or persistent infection that might worsen with immunosuppressive treatment. - Patients known to be seropositive for HBV or have active HBV infection. - Serious underlying medical conditions, which per the investigator's discretion could impair the ability of the patient to participate in the trial. - Patients with uncontrolled hypertension. - Known sensitivity 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 drug. - Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. - Treatment within a clinical trial within 4 weeks prior initiation of trial treatment. - Refusal from patients with reproductive potential (males and females), of use of a medically acceptable method of contraception during the trial, i.e., a combination of two forms of effective contraception. - Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to compare the efficacy (best overall response rate after completion of induction therapy) of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular lymphoma; Secondary Objective: 1/ To assess Progression Free Survival (PFS), Time to Treatment Failure (TTF) and Overal Survival (OS) 2/ To evaluate safety and immunogenicity ;Primary end point(s): The primary efficacy endpoint of the trial is the best overall response rate (CR+PR) after completion of induction therapy, as defined by the modified IWG Criteria, 2007, using the investigator’s assessment.;Timepoint(s) of evaluation of this end point: Tumor assessment and Response assessment are performed after 3 cycles of induction treatment, at the end of induction therapy and every 6 months during maintenance therapy. The primary analysis (best overall response rate [CR+PR]), will be performed after all patients have had tumor response assessments performed on completion of induction therapy or earlier if no more patients are expected to complete induction therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are Progression Free Survival, Time to Treatment Failure, Overall Survival and immunogenicity. An additional secondary endpoint is to evaluate safety of BI 695500 by means of Adverse Events, laboratory tests, physical examination, vital signs and 12¬lead electrocardiogram (ECG). ; Timepoint(s) of evaluation of this end point: Tumor assessment and Response assessment are performed after 3 cycles of induction treatment, at the end of induction therapy and every 6 months during maintenance therapy. Suvival will be assessed throughout the trial from C1 to End of Maintenance visit. Anti-drug antibodies will be assessed at C1, C4, C6,End of Induction, every 8 weeks during maintenance, at End of Maintenance visit. Timepoints for safety endpoint: Safety enpoints are checked at each study visit. | — |
Countries
Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed