Evidence map›Paper›PMID 31809224›Full record

Trial reportJournal of global oncology2019

Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma.

Auro Viswabandya, Sandip Shah, Asis Mukhopadhyay, Rajnish Vasant Nagarkar, Sonica Sachdeva Batra, Luis Lopez-Lazaro, Suresh Kankanwadi, Alok Srivastava

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of global oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Early detection of gastrointestinal cancers in low- and middle-income countries: A risk-stratified framework and implementation roadmap.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Review
  9. Article
  10. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabTheraTherapeutic advances in medical oncology · 2025
    Article
  11. Relationship between using cancer resource center services and patient outcomes.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 2 countries.

Auro ViswabandyaChristian Medical College, Vellore, India.
Sandip ShahVedanta Institute of Medical Sciences, Ahmedabad, India.
Asis MukhopadhyayNetaji Subhash Chandra Bose Cancer Research Institute, Kolkata, India.
Rajnish Vasant NagarkarCurie Manavata Cancer Centre, Nashik, India.
Sonica Sachdeva BatraDr Reddy's Laboratories, Hyderabad, India.
Luis Lopez-LazaroDr Reddy's Laboratories, Basel, Switzerland.
Suresh KankanwadiDr Reddy's Laboratories, Basel, Switzerland.
Alok SrivastavaChristian Medical College, Vellore, India.
Christian Medical College & Hospital · INDr. Reddy's Laboratories (Switzerland) · CHCare Institute of Medical Sciences · INDr. Reddy's Laboratories (India) · INHCG Cancer Centre · INNetaji Subhas Chandra Bose Cancer Research Institute · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared. PATIENTS AND

methodsWe conducted a double-blind, parallel-group study in patients with untreated DLBCL who were eligible to receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Patients were randomly assigned at a one-to-one ratio to receive DRL_RI or RMP for six 21-day cycles of rituximab plus CHOP, with 18 months of follow-up after day 1, cycle 6 (C6). Primary end point was C1 PKs, measured as area under the plasma concentration-time curve from day 0 to 21 (AUC

resultsA total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75). DRL_RI/RMP GMRs for AUC

conclusionDRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveBiosimilar PharmaceuticalsCyclophosphamideDouble-Blind MethodDoxorubicinFemaleHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPrednisoneRituximabTreatment OutcomeVincristineBiosimilar PharmaceuticalsCyclophosphamideDoxorubicinPrednisoneRituximabVincristine

Identifiers

PMID31809224
PMCPMC6939748
OpenAlexW2992331654

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.