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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)


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Lymphoma, B-Cell

Thank you

Trial Information

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)


Inclusion Criteria:



- Adult patients, >/= 18 and
- 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
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate (CR/CRu) , assessed by Investigator according to International Working Group criteria (Cheeson et al., 1999), at the end of induction treatment

Outcome Time Frame:

approximately 21 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Study ID:

MO28107

NCT ID:

NCT01649856

Start Date:

August 2012

Completion Date:

June 2016

Related Keywords:

  • Lymphoma, B-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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