A clinical trial to compare safety and efficacy of two formulations of Rituximab, both being administered in combination with CHOP chemotherapy regimen, in patients with Diffuse Large B-Cell Lymphoma (DLBCL)

A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/09/004959

Enrollment

250

Registered

2014-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diffuse large B-cell lymphoma (DLBCL)

Interventions

Intervention1: Rituximab BioSimilar: Rituximab 10 mg/mL (9 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dehydrate, 0.7 mg/mL polysorbate 80 (Tween 80), sterile water for injection, pH adjusted to

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L. Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval. 2. Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkinâ??s lymphoma (DLBCL) with untreated CD20+. Defined by the local Haematopathologist at the local laboratory according to WHO criteria. 3. Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification. 4. Age-adjusted International Prognostic Index (IPI) score 0 or 1. 5. Age >=18 to 6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of 7. Written informed consent obtained before starting any study specific procedure. 8. Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intramuscular contraceptive).

Exclusion criteria

Exclusion criteria: 1. Life expectancy of less than three months. 2. Any other lymphoma other than CD20+ DLBCL.

Design outcomes

Primary

Measure	Time frame
Response Rate (RR): Tumour responses will be assessed after 6 cycles of chemotherapy or at the end of treatment and classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) according to the International Working Group criteria.Timepoint: Response Rate (RR): Tumour responses will be assessed after 6 cycles of chemotherapy or at the end of treatment and classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) according to the International Working Group criteria.	—

Measure

Time frame

Response Rate (RR): Tumour responses will be assessed after 6 cycles of chemotherapy or at the end of treatment and classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) according to the International Working Group criteria.Timepoint: Response Rate (RR): Tumour responses will be assessed after 6 cycles of chemotherapy or at the end of treatment and classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) according to the International Working Group criteria.

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Secondary

Measure	Time frame
Event Free Survival: Time to progressive disease under therapy, the events for which being: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, death from any cause, whichever comes first. Safety : AEs will be collected during the study and up to 30 days after the end of study treatment (graded according to the NCICTC criteria [v 4.0]).Timepoint: At the End of study.	—

Measure

Time frame

Event Free Survival: Time to progressive disease under therapy, the events for which being: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, death from any cause, whichever comes first. Safety : AEs will be collected during the study and up to 30 days after the end of study treatment (graded according to the NCICTC criteria [v 4.0]).Timepoint: At the End of study.

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Countries

Argentina, Brazil, Colombia, India, Indonesia, Malaysia, Mexico, Paraguay, Philippines, Russian Federation, South Africa, Thailand, Venezuela (Bolivarian Republic of)

Contacts

Public ContactDr Chirag Shah

Cliantha Research Limited

cgautam@clianthatrials.com07966135655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026