Clinical trial · Interventional
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. Subjects were randomized in a 1:1 ratio to receive a 375 mg/m\^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABP 798
- description
- ABP 798 was administered at a dose of 375 mg/m\^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
- interventionNames
- Biological: ABP 798
- type
- ACTIVE_COMPARATOR
- label
- Rituximab
- description
- Rituximab was administered at a dose of 375 mg/m\^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
- interventionNames
- Biological: Rituximab
Primary outcomes (1)
- measure
- Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDNiederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, Hanes V, Delwail V, Hajek R, Chien D. Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. Target Oncol. 2020 Oct;15(5):599-611. doi: 10.1007/s11523-020-00748-4. PMID 33044684