Phase 3
Completed N=256
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT02747043 ↗
Enrolled (actual)
256
Serious AEs
3.9%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease — 78.0; 70.2 percentage of participants
◆ Published Evidence
Emerging
19citations · ~3 / year
Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.
Summary
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.
Linked Publications
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Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease |
78.0; 70.2 | — |
| SECONDARY Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease |
59.3; 58.1 | — |
| SECONDARY Pharmacokinetic Serum Concentrations by Visit |
58.66; 58.63; 105.39; 108.77; 132.70; 140.23 | — |
| SECONDARY Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8 |
98.3; 98.3 | — |
| SECONDARY Total Immunoglobulin G (IgG) Results by Visit |
9.740; 10.570; 9.790; 10.486; 9.545; 10.374 | — |
| SECONDARY Total Immunoglobulin M (IgM) Results by Visit |
1.021; 1.247; 1.004; 1.280; 1.001; 1.370 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events |
107; 95; 14; 13; 0; 0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs) |
49.2; 45.2; 43.0; 42.9; 5.5; 4.8 | — |
| SECONDARY Number of Participants Who Developed Anti-drug Antibodies |
3; 1; 1; 1 | — |
| SECONDARY Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease |
3.1; 2.4; 96.9; 97.6 | — |
| SECONDARY Percentage of Participants Who Survived -- Overall Survival (OS) |
100; 100 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02747043) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.