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A Therapeutic and side effects comparison between Reditux and brand tpe (Mabthera) in Diffuse Large B Cell Lymphoma (DLBCL)

A therapeutic and side effects’ comparison between Reditux and brand type (MabThera) in Diffuse Large B Cell Lymphoma (DLBCL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201010124920N1
Enrollment
30
Registered
2011-08-02
Start date
2011-08-07
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Diffuse large B cell lymphoma (DLBCL). Diffuse non-Hodgkin's lymphoma, Large cell (diffuse)

Interventions

Intervention 1: Mabthera (375 mg/m2) every 3 weeks for 6 months (8 courses). Intervention 2: Reditux (375 mg/m2) every 3 weeks for 6 months (8 courses).
Treatment - Drugs
Mabthera (375 mg/m2) every 3 weeks for 6 months (8 courses)
Reditux (375 mg/m2) every 3 weeks for 6 months (8 courses)

Sponsors

Cinnagen Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: DLBCL patients 18 to 65 years old (male & female); CD 20 marker positivity; Completion of informal consent. Exclusion criteria: Recurrence DLBCL; Systolic dysfunction (EF3; Advanced Liver or renal dysfunctions (Bil T >6 mg/dl or Cr >4 mg/dl).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Radiographic response rate. Timepoint: At the end of quarter and end of treatment. Method of measurement: Radiography ( CT–Scan/ MRI ).

Secondary

MeasureTime frame
Hematologic response rate, Partial remission and Complete remission. Timepoint: Three weeks (end of treatment), hematologic evaluation is done and the next course of treatment is started. And at the end of the fourth and eighth radiologic evaluation occurs. Method of measurement: The variables measured in blood; through the blood and bone marrow radiological assessment if necessary.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sina Salari

Taleghani Hospital, Shahid Beheshti University of Medical Sciences

dr.sinasalari@yahoo.com+98 21 2243 2560

Outcome results

None listed

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