BI 695500 vs Rituxan first line treatment in patients with Low Tumor Burden Follicular Lymphoma

Conditions: ow tumor burden follicular lymphoma
MedDRA version: 18.0Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-004544-36-ES

Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

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, including:
- hemoglobin ? 9.0 g/dL (? 5.6 mmol/L).
- absolute neutrophil count (ANC) ? 1.5 × 109/L.
- platelet count ? 100 × 109/L.
10. Adequate renal and liver function:
- serum creatinine < 2.0 mg/dL (< 176.8 mcmol/L).
- total bilirubin < 2.0 mg/dL (< 34 mcmol/L) except for patients with Gilbert?s Syndrome or hemolysis. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × upper limit of normal (ULN) (< 5 × ULN is acceptable if abnormalities are thought to be related to hepatic infiltration by FL).
11. For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial, i.e., a combination of 2 forms of effective contraception. Females of childbearing potential (includes tubal ligation) and males with female partners of childbearing potential must also agree to use an acceptable method of contraception for 12 months following completion or discontinuation from the trial medication.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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. HIV and TB screening test will be performed according to local practice and local regulatory guidance. Patients who are confirmed positive (e.g., positive TB test followed by a chest x-ray (CXR) for confirmation) and those who have active infections are excluded from the trial participation.
8. Patients with serological evidence of HBV infection.
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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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