A clinical trial to study the effects of Rituximab injection (Hetero) in Indian patients suffering from varieties of Non-Hodgkins Lymphoma.

Phase 3

Completed

• Conditions: Health Condition 1: null- Adult patients with newly diagnosed or previously untreated Non-Hodgkins LymphomaHealth Condition 2: C859- Non-Hodgkin lymphoma, unspecified

• Registration Number: CTRI/2013/08/003921
• Lead Sponsor: Hetero Drugs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

•The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures

•Male or Female >=18 years and <=65 years of age (both inclusive)

•Histologically confirmed CD20-positive- Newly diagnosed diffuse large B-cell Non-Hodgkinâ??s lymphoma OR Previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy

•Patients who are eligible for rituximab and CHOP

•Patients with at least one measurable lesion as per International Working Group Response Criteria for Malignant Lymphoma

•Adequate liver, renal, cardiac and haematological functions

•Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG)

•Life expectancy more than six months

•No other serious illness that according to investigator might jeopardize the well-being, the safety of study subjects, the compliance to study medications and validity of data generated during the study.

Exclusion Criteria

• Hypersensitivity reactions with murine proteins or planned chemotherapy

•Diffuse lymphoma for which CHOP is not adequate therapy

•Bulky Disease (10 cm on maximum dimension) or involves 1/3 of chest diameter (on radiographic imaging)

•Need for emergency therapy such as neurologic compression syndrome

•Subjects with CNS involvement or CNS lymphoma (Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification)

•Patient treated with prior chemotherapy including not limited to Anthracyclines, Rituximab, anti-CD-20 therapy or autologous or allogeneic stem cell transplantation

•Any radiotherapy given for lymphoma or non-lymphoma before 30 days of planned treatment

•Symptomatic peripheral neuropathy (>=Grade 2,Common Terminology Criteria of Adverse Events [CTCAE v 4.03)

•Patients using systemic antibiotic therapy 30 days prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified