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



Status:Active, not recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:May 25, 2016
End Date:July 17, 2019

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A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)

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.


Inclusion Criteria:

- Males and females 18 years of age and older

- 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 6 weeks 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 splenomegaly > 16cm by CT scan and no symptomatic splenomegaly

- no significant pleural or peritoneal serous effusions by CT

- lactate dehydrogenase ≤ upper limit of normal (ULN)

- 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 metastases

- 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)

- Other investigational procedures that can impact the study data, results, or patient
safety while participating in this study are excluded; participation in observational
studies is allowed.

- 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)

- Systemic corticosteroid use within 3 months before randomization (inhaled are
allowable)
We found this trial at
8
sites
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mi
from
Zanesville, OH
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from
Billings, MT
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Encinitas, CA
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from
Gosford,
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from
Mount Sterling, KY
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from
Oklahoma City, OK
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mi
from
Roanoke, VA
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mi
from
Vallejo, CA
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