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).

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/08/007226

Enrollment

1000

Registered

2016-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Non-Hodgkins Lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
To collect data on usage of Mabtas in India with specific reference to NHL and CLL patients to evaluate: 1. The safety of Mabtas in patients of NHL and CLL. 2. To evaluate response to the Mabtas treatment in patients of NHL and CLL.Timepoint: 1 year	—

Secondary

Measure	Time frame
1.To evaluate the epidemiology and co-morbid conditions associated with NHL and CLL in the Indian scenario. 2.To evaluate thedrug usage pattern in relation to patientâ??s profile of NHL and CLL. 3. To obtain data on parameters governing the preference of various chemotherapy regimens for management of NHL and CLL.Timepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Deepak Bunger

Intas Pharmaceuticals Limited

deepak_bunger@intaspharma.com079-66117410

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026