IRCT201305296302N5
Completed
Phase 3
A comparative study for efficacy and safety between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- chronic lymphocytic lukemia.
- Sponsor
- AryoGen Biopharma company
- Enrollment
- 78
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 4
To study the comparison of efficacy and safety between injection iron sucrose complex and injection ferric carboxymaltose in the treatment of moderate anemia in pregnancy.CTRI/2024/03/064066GMERS Medical college and hospital Gotri,Vadodara
Not yet recruiting
Not Applicable
A study comparing the safety and effectiveness of two anesthetic mixtures for cataract surgery.Health Condition 1: H259- Unspecified age-related cataractCTRI/2024/08/072068Dr Jai Pavan Siddharth
Completed
Not Applicable
COMPARASION OF DIFFERENT CORTICOSTEROIDS TO STUDY SAFETY REGARDING FETAL AND MATERNAL OUTCOMEHealth Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperiumCTRI/2022/12/048113SHRI B M PATIL MEDICAL COLLEGE AND HOSPITA192
Recruiting
Not Applicable
â??COMPARING THREE DIFFERENT TREATMENT MODALITIES IN PATCHY HAIR LOSS â??Health Condition 1: null- Patients with patchy hair lossCTRI/2013/08/003880Self60
Unknown
Not Applicable
Is spinal anaesthesia more safe and effective than general anaesthesia for open surgery of gall bladder?Health Condition 1: null- Uncomplicated symptomatic gallstone disease with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI â?¤ 30 kg/m2CTRI/2015/04/005715Dr Ram Bhakta Koju120