CTRI/2016/08/007226
Recruiting
Phase 4
A Prospective, Multi Centre, Observational, Data Collection Registry Study To Monitor The Routine Clinical Use Of Mabtas (Rituximab 100 Mg / 500 Mg Concentrate For Solution For Infusion, Manufactured By Intas Pharmaceuticals Ltd) In Indian Patients. - Mabtas registry
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Intas Pharmaceuticals Limited
- Enrollment
- 1000
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult male or female patients, newly diagnosed with NHL and CLL, and who require treatment with MABTAS therapy will be enrolled.
- •2\. The diagnosis and staging of NHL \& CLL should be confirmed on the basis of pathology report available with the patients. However, patient of NHL should have one measurable lesion (Nodal lesion: 1\.5 cm in longest diameter or non\-nodal: \>1\.0 x 1\.0 cm) as per International Working Group Response Criteria for Malignant Lymphoma.
- •3\. Patients willing to provide informed consent.
Exclusion Criteria
- •1\. Patients with any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results.
- •2\.Patient with a history of hypersensitivity reactions or contraindication to the excipients of planned chemotherapy regimen.
Outcomes
Primary Outcomes
Not specified
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