This study will be performed for evaluation of therapeutic as well as side effects of Reditux compared with Mabthera with bio-similar properties. Our hypothesis is that these two drugs have similar efficacy in outcome of Diffuse Large B Cell Lymphoma (DLBCL) patients. This study is a parallel design, randomized double blind clinical trial as well as an equivalence/ non inferiority trial. Patients with diagnosis of DLBCL whose diagnoses were confirmed by CD20 positivity in IHC or flow cytometery will be included. Then, the patients will be entered onto the two arms based on balanced permuted block randomization. Patients in the two arms will be treated with Reditux or Mabthera (375 mg/m2) every 3 weeks. Duration of treatment is 6 months (8 courses). Staging is done for all the patients in beginning of treatment. All para-clinical assessments (biochemistry, radiologic, pathologic, radionuclide) will be performed in one center in accordance with uniform standards. A questionnaire will be completed for every patient including demographic data and other information.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010124920N1
Registration date:2011-08-02, 1390/05/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-02, 1390/05/11
Registrant information
Name
Ramin Heshmat
Name of organization / entity
Chronic Diseases Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0086
Email address
rheshmat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cinnagen Company
Expected recruitment start date
2011-08-07, 1390/05/16
Expected recruitment end date
2013-08-07, 1392/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A therapeutic and side effects’ comparison between Reditux and brand type (MabThera) in Diffuse Large B Cell Lymphoma (DLBCL)
Public title
A Therapeutic and side effects comparison between Reditux and brand tpe (Mabthera) in Diffuse Large B Cell Lymphoma (DLBCL)
Purpose
Treatment
Inclusion/Exclusion 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 (EF<50%); HIV, HBV, HCV markers positivity; History of organ transplantation of other active malignancy; History of allergy to monoclonal antibodies; ECOG performance status >3; Advanced Liver or renal dysfunctions (Bil T >6 mg/dl or Cr >4 mg/dl).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Evin, Chamran Highway
City
Tehran
Postal code
198517413
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
400/2818
Health conditions studied
1
Description of health condition studied
Diffuse large B cell lymphoma (DLBCL)
ICD-10 code
C83.3
ICD-10 code description
Diffuse non-Hodgkin's lymphoma, Large cell (diffuse)
Primary outcomes
1
Description
Radiographic response rate
Timepoint
At the end of quarter and end of treatment
Method of measurement
Radiography ( CT–Scan/ MRI )
Secondary outcomes
1
Description
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
Intervention groups
1
Description
Mabthera (375 mg/m2) every 3 weeks for 6 months (8 courses)
Category
Treatment - Drugs
2
Description
Reditux (375 mg/m2) every 3 weeks for 6 months (8 courses)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Sina Salari
Street address
Evin st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cinnagen Company
Full name of responsible person
Dr.Ali Bamdad
Street address
Fifth Floor, No. 56, Azimi St, Ekbatan Phase 1
City
Tehran
Grant name
طبق قرارداد ١٠٢١٣٧-٨٩ مورخ ٢٠/١/١٣٩٠
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cinnagen Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Taleghani Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sina Salari
Position
Fellowship of Hematology-Oncology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Evin St.
City
Tehran
Postal code
198517413
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dr.sinasalari@yahoo.com
Web page address
www.taleghanihospital.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Taleghani Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Abbas Haji Fath Ali
Position
Associate Professor, Speciality in Hematology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Evin St.
City
Tehran
Postal code
Phone
+98 21 2243 2580
Fax
Email
hajifathali@yahoo.com
Web page address
www.taleghanihospital.ir
Person responsible for updating data
Contact
Name of organization / entity
Taleghani Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Sina Salari
Position
Fellowship in Hematology-Oncology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Evin St.
City
Tehran
Postal code
198517413
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dr.sinasalari@yahoo.com
Web page address
www.taleghanihospital.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)