A Prospective, Multi Centre, Observational, Data Collection Registry Study To Monitor The Routine Clinical Use Of Mabtas in Indian Patients with Non-Hodgkins lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL).
- Conditions
- Health Condition 1: null- Non-Hodgkins Lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
- Registration Number
- CTRI/2016/08/007226
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method