A comparative study for efficacy and safety between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)
The objective of this randomized, double blind trial is to compare the efficacy and safety of Mabthera® and Zitux (Rituximab manufactured by AryoGen) on patients with chronic lymphocytic leukemia (CLL) .In this study, 60 patients with CLL who meet the inclusion/exclusion criteria will be recruited and randomly assigned equally into two intervention or a control group. The patients in the intervention group will receive Zitux and in the control group will receive Mabthera® as same dosage and form.response to treatment according to national cancer institute response to treatment criteria for CLL will be measured after the intervention and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305296302N5
Registration date:2013-06-07, 1392/03/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Kamran Kamyar
Name of organization / entity
AryoGen Biopharma Company
Country
Iran (Islamic Republic of)
Phone
00982616102587،00982616101568
Email address
kamyark@aryogen.com
Recruitment status
Recruitment complete
Funding source
AryoGen Biopharma Company
Expected recruitment start date
2013-08-09, 1392/05/18
Expected recruitment end date
2013-12-09, 1392/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study for efficacy and safety between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)
Public title
A comparative study between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient with chronic lymphocytic leukemia according to national cancer institute diagnostic criteria for CLL who hasn't been treated already or is new case of CLL or relapsed/refractory CLL with indication for treatment; Age between 18 to 75; Binet stage disease B,C; ECOG performance status: 0 to 1; CD20 positive; patient has indication for treatment in the beginning of study; written informed consent form. exclusion criteria: Bil>2 mg/dl; Cr> 2 mg/dl; Alk-p> 2 times of upper limit normal; Trans aminase > 2 times of upper limit normal; Coexistence of serious active infection or underlying disorder( Hepatitis B,C, HIV positive, cardiopulmonary disease, recent MI, uncontrolled diabetes or HTN, seizure); HBSAg or HBCAb positive; other cancer treatments in the last 5 years; severe autoimmune hemolytic anemia, pregnancy or breast feeding
exclusion criteria: Bil>2 mg/dl; Cr> 2 mg/dl; Alk-p> 2 times of upper limit normal; Trans aminase > 2 times of upper limit normal; Coexistence of serious active infection or underlying disorder( Hepatitis B,C, HIV positive, cardiopulmonary disease, recent MI, uncontrolled diabetes or HTN, seizure); HBSAg or HBCAb positive; other cancer treatments in the last 5 years; severe autoimmune hemolytic anemia, pregnancy or breast feeding
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
78
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
Ethics committee of Iranian Blood Transfusion Organization
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Postal code
14665-1157
Approval date
2013-03-16, 1391/12/26
Ethics committee reference number
پ/378
Health conditions studied
1
Description of health condition studied
chronic lymphocytic lukemia
ICD-10 code
C91.1
ICD-10 code description
Chronic lymphocytic leukaemia of B-cell type
Primary outcomes
1
Description
Overall response rate according to national cancer institute response to treatment criteria
Timepoint
2 and 4 months after beginning of treatment
Method of measurement
physical exam and laboratoty results according to national cancer institute response to treatment criteria
Secondary outcomes
1
Description
Complete response rate
Timepoint
2 and 4 months after beginning of treatment
Method of measurement
physical exam and laboratoty results according to national cancer institute response to treatment criteria
2
Description
Partial response rate
Timepoint
2 and 4 months after beginning of treatment
Method of measurement
physical exam and laboratoty results according to national cancer institute response to treatment criteria
3
Description
Stable disease rate
Timepoint
2 and 4 months after beginning of treatment
Method of measurement
physical exam and laboratoty results according to national cancer institute response to treatment criteria
4
Description
Progressive disease rate
Timepoint
2 and 4 months after beginning of treatment
Method of measurement
physical exam and laboratoty results according to national cancer institute response to treatment criteria
5
Description
CD20 reduction rate
Timepoint
monthly after beginning of treatment
Method of measurement
flucytometery
6
Description
Complete response rate according to flucytometery
Timepoint
monthly after beginning of treatment
Method of measurement
flucytometery
7
Description
side effect rate, fever
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
8
Description
side effect rate, cardiovascular
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
9
Description
side effect rate, digestive
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
10
Description
side effect rate, hematologic
Timepoint
monthly during 4 months of treatment
Method of measurement
laboratoty results
11
Description
side effect rate, metabolic
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam and laboratoty results
12
Description
side effect rate, Musculoskeletal
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
13
Description
side effect rate, respiratory
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
14
Description
side effect rate, skin
Timepoint
monthly during 4 months of treatment
Method of measurement
physical exam
Intervention groups
1
Description
intervention group: combination therapy with (Fludarabine, Cyclophosphamide, Zitux) for 4 cycle with 28 days intervals as below:
first treatment cycle:
Zitux: 375 mg/m2 IV in first day
Fludarabine: 25 mg/m2 IV in second to forth day
Cyclophosphamide: 250 mg/m2 IV in second to forth day
second to forth treatment cycles:
Zitux: 500 mg/m2 IV in first day
Fludarabine: 25 mg/m2 IV in first to third day
Cyclophosphamide: 250 mg/m2 IV in first to third day
Category
Treatment - Drugs
2
Description
control group: combination therapy with (Fludarabine, Cyclophosphamide, Reditux) for 4 cycle with 28 days intervals as below:
first treatment cycle:
Reditux: 375 mg/m2 IV in first day
Fludarabine: 25 mg/m2 IV in second to forth day Cyclophosphamide: 250 mg/m2 IV in second to forth day
second to forth treatment cycles:
Zitux: 500 mg/m2 IV in first day
Fludarabine: 25 mg/m2 IV in first to third day Cyclophosphamide: 250 mg/m2 IV in first to third day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Blood Transfusion Organization
Full name of responsible person
Dr. Gholamreza Toogeh
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AryoGen Biopharma company
Full name of responsible person
Dr. Behrouz Vaziri
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
City
Garmdareh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryoGen Biopharma 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
AryoGen Biopharma company
Full name of responsible person
Dr. Kamran Kamyar
Position
General Practitioner/ Medical Manager
Other areas of specialty/work
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
City
Garmdareh
Postal code
Phone
+98 263610156872
Fax
Email
kamyark@aryogen.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Blood Transfusion Organization
Full name of responsible person
Dr. Mohammad Faranoush
Position
Pediatric Hematologist Oncologist Associate Professor
Other areas of specialty/work
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Postal code
Phone
+98 21 8860 5151
Fax
Email
faranoush47@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Kamran Kamyar
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)