Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 250
• Participant gender: Both

Summary

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.

This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Rituximab
• Last Updated: 2016-11-04

Criteria

Inclusion Criteria:

• Males and females ≥ 18 and < 80 years of age

• Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization

• Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)

• subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 28 days before randomization

• subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening.

• Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria

• largest nodal or extranodal mass ≤ 7 cm

• no more than 3 nodal sites with diameter > 3 cm

• no spleen enlargement by CT assessment

• no significant pleural or peritoneal serous effusions by CT

• normal lactate dehydrogenase (LDH)

• no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)

Exclusion Criteria:

• Diffuse large cell component and/or Grade 3b follicular NHL

• History or known presence of central nervous system metastase

• Palliative radiotherapy within 3 months before randomization

• Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)

• Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)

• Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)

• Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)