A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01649856
First received: July 23, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituxim ab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to rece ive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycl es of CHOP chemotherapy. Anticipated time on study treatment is 6 months.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: rituximab [MabThera/Rituxan]
Drug: CHOP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative, Randomized, Parallel-group, Multi-centre, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20 Positive Diffuse Large B-cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Complete response rate (CR/CRu) , assessed by Investigator according to International Working Group criteria (Cheeson et al., 1999), at the end of induction treatment [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction: Validated Cancer Treatment Satisfaction Questionnaire (CTSQ)/Rituximab Administration Satisfaction Questionnaire (RASQ) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Administration times (iv versus sc) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Rituximab SC Drug: rituximab [MabThera/Rituxan]
The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
Drug: CHOP
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
Active Comparator: B: Rituximab IV Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
Drug: CHOP
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 and </= 80 years of age at time of study inclusion
  • Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
  • Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion >/= 7.5 cm
  • At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
  • Adequate hematologic function
  • Eastern Cooperative Oncology Group (EOCD) performance status </= 2

Exclusion Criteria:

  • Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
  • Transformed lymphoma or follicular lymphoma IIIB
  • Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
  • History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
  • Inadequate renal or hepatic function
  • Known human immunodeficiency virus (HIV) infection or HIV seropositive status
  • Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649856

Contacts
Contact: Reference Study ID Number: MO28107 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 186 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01649856     History of Changes
Other Study ID Numbers: MO28107, 2012-000669-19
Study First Received: July 23, 2012
Last Updated: August 19, 2014
Health Authority: Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014