BI 695500 safety and efficacy study in patients with untreated follicular non-Hodgkin's lymphoma.

Active, not recruiting

• Conditions: ntreated stage III or IV non-Hodgkin's lymphoma (CD20+Follicular Lymphoma of Grade 1, 2 or 3, requiring chemotherapy); MedDRA version: 14.1Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002908-33-IT
• Lead Sponsor: BOEHRINGER INGELHEIM INTERNATIONAL GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-30
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

1.Male or female patients, at least 18 years of age at Screening. 2.Untreated, histologically confirmed, stage III or IV NHL (CD20+Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemiotherapy) 3. 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 4. ECOG performance status of 0 to 2. 5. Have a t least one measurable lesion as per the IWG criteria 2007 at Screening 6. Adequate hematological functions (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization, including: • Hemoglobin = 8,0 g/dL (= 5,0 mmol/L). • Absolute neutrophl count= 1,5 x 109/L. • Platelet count= 100 x 109/L. 7. Adequate renal and liver function. 8. 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: 0
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

1. Transformation to high-grade lymphoma (secondary to low grade lymphoma). 2. Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis). 3. Patients regularly taking oral corticosteroids must not be receiving a dose exceeding 20 mg/day prednisolone or equivalent. 4. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, idarubicin and /or other anthracyclines and anthracenediones. 5. Patients with prior or concomitant magignancies 6. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization. 7. Poor renal function: serum creatinine > 2.0 mg/dL (> 197 mcmol/L). 8. Poor hepatic function: total bilirubin > 2.0 mg/dL (> 34 mcmol/L) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, unless these abnormalities are related to lymphoma. 9. Active, chronic or persistent infection that might worsen with immunosuppressive treatment 10. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial 11. Patients with uncontrolled hypertension. 12. Known sensitivity or allergy to murine products. 13. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug. 14. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. 15. Treatment within a clinical trial within 4 weeks prior to trial entry. 16. Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified