Health Condition 1: null- Adult patients with newly diagnosed or previously untreated Non-Hodgkins Lymphoma Health Condition 2: C859- Non-Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: Rituximab (Hetero): Rituximab (Hetero) 375 mg/m2 should be administered on Day 1 of each chemotherapy cycle in combination with cyclophosphamide, doxorubicin, vincristine and predniso
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
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 • 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response rate (ORR) by International Working Group (IWG) response criteriaTimepoint: At baseline, end of cycle 3 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: CD19 counts Pharmacokinetics:Cmax, Tmax & AUC Immunogenicity: Anti-Rituximab antibodies Safety:Adverse events-significant clinical signs, symptoms & laboratory abnormalities during treatmentTimepoint: Pharmacodynamics:Baseline, end of cycle 3 and 6 Pharmacokinetics:Cycle 1 and 6 Immunogenicity:Baseline, end of cycle 3 and 6 | — |
Countries
India
Contacts
Public ContactDr Rudolph Julius D Almeida
Hetero Group
Outcome results
None listed