To study the effects of two drugs, R-TPR-017 and Mabthera® (Ristova®) in cancer patients (Non-Hodgkinâ??s Lymphoma)
- Conditions
- Health Condition 1: null- Patients with Non-Hodgkinâ??s Lymphoma
- Registration Number
- CTRI/2011/12/002232
- Lead Sponsor
- Reliance Life sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
1. Previously untreated patients
2. Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma
3. CD20 positive by immunohistochemistry
4. Patients with at least one target lesion (lymph node with short axis of less than or equal to 15 mm by CT scan with contrast)
5. ECOG performance status 0 to 2
6. Life expectancy more than six months
7. Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements
8. Consent from Legally Acceptable Representative (LAR), if subject is not in a condition to give consent. However, when the subject is stable and is able to give consent, the consent would be obtained on a separate ICF to confirm his/her willingness to continue participation in the study.
1. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
2. Patients with prior or concomitant malignancy
3. Patients with abnormal laboratory parameters like:
•Serum creatinine 2.0 times of upper normal limit
•AST or ALT 2.5 times of upper normal limit
•Alkaline phosphatase >=1.5 times of upper normal limit
•Platelet count 100,000/ZL.
•Hemoglobin 8.0 g/dL.
•Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
•Serum Immunoglobulin G (IgG) level 3.0 g/L
4. History of prior chemotherapy, stem cell transplant and radiotherapy
5. History of high dose, systemic, steroid therapy within 6 weeks
6. Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins
7. Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection)
8. Severe cardiovascular disease within 12 months including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension
9. Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study
10. Subjects with HIV, HBsAg, HCV test positive
11. Subject participation in another clinical trial 30 days prior to administration of IP
12. Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteriaTimepoint: at 24 weeks
- Secondary Outcome Measures
Name Time Method Proportion of patients with Objective Response Rate {Complete Response and Partial Response} assessed by RECIST 1.1 criteriaTimepoint: At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year