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)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/004959
• Date of registration: 02-09-2014
• Prospective Registration: Yes
• Primary sponsor: MABXIENCE SA
• Public title: 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)
• Scientific title: 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.
• Date of first enrolment: 19-09-2014
• Target sample size: 250
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9934
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Dr Charu Gautam
• Affiliation: Cliantha Research Limited

• Name: Dr Chirag Shah
• Affiliation: Cliantha Research Limited

Key inclusion & exclusion 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 <=65 years of age.

6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of <=2.

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: 1. Life expectancy of less than three months.

2. Any other lymphoma other than CD20+ DLBCL.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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
6.5). 375 mg/m2 intravenous (I.V.),every 3 weeks on Day 1 of the CHOP regimen, with a total of 6 cycles
Control Intervention1: Mabthera® (Roche): Rituximab BioSimilar RTXM83: 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
6.5). 375 mg/m2 intravenous (I.V.), every 3 weeks on Day 1 of the CHOP
regimen, with a total of 6 cycles

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

RTXM83-AC-01-11, Version 1.0 dated 05 Mar 12

Source(s) of Monetary Support

MABXIENCE SA

Ethics review

Status: Approved
Approval date: 11/06/2013
Contact:

Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi

Status: Approved
Approval date: 12/07/2013
Contact:

Health Point Ethics Committee, Kolkata

Status: Approved
Approval date: 30/07/2013
Contact:

Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata

Status: Approved
Approval date: 19/09/2013
Contact:

Institutional Ethics Committee, BIBI General Hospital and Cancer Centre, Hyderabad

Status: Approved
Approval date: 23/09/2013
Contact:

O & P institutional Ethics Committee, Pune

Status: Approved
Approval date: 29/12/2014
Contact:

SCCH- Institutional Ethics Committee

Status: Not Approved
Approval date:
Contact:

Cancer institute Ethics Committee, Dr. Krishnamurthy Campus, Adyar, Chennai

Status: Not Approved
Approval date:
Contact:

Ethics Committee of SMS Medical College and attached Hospitals, Jaipur

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee IHTM Medical College Kolkata