A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)

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Roche

Status and phase

Completed
Phase 3

Conditions

Lymphoma

Treatments

Drug: Rituximab
Drug: Doxorubicin
Drug: Bendamustine
Drug: Vincristine
Drug: Cyclophosphamide
Drug: Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01889069
ML28881
2013-000647-12 (EudraCT Number)

Details and patient eligibility

About

This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.

Enrollment

159 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification system
  • Currently being treated with rituximab intravenously (IV) in the Induction or Maintenance period, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square-meter (mg/m^2) administered without interruption or early discontinuation (i.e. tolerability issues)
  • Expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the Induction period or 6 additional cycles of treatment during the Maintenance period (participants with follicular NHL)
  • An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion greater than or equal to (>=) 7.5 centimeters (cm), or Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high risk) assessed before the first rituximab IV administration in Induction period
  • At least one bi-dimensionally measurable lesion defined as >=1.5 cm in its largest dimension on computed tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 3

Exclusion criteria

  • Transformed lymphoma or FL IIIB
  • Primary central nervous system lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, or primary cutaneous DLBCL
  • History of other malignancy
  • Ongoing corticosteroid use greater than (>) 30 milligrams per day (mg/day) of prednisone or equivalent
  • Inadequate renal, hematologic, or hepatic function
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindications to any of the individual components of standard chemotherapy
  • Other serious underlying medical conditions, which, in the Investigator's judgement, could impair the ability of the participant to participate in the study
  • Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)
  • Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

159 participants in 1 patient group

Rituximab
Experimental group
Description:
Participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
Treatment:
Drug: Prednisone
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Bendamustine
Drug: Doxorubicin
Drug: Rituximab

Trial documents
2

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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