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Phase 4
18 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed CD20+ indolent non-Hodgkin's lymphoma according to WHO
classification system

- Patients must have received and must have relapsed or been refractory to one or more
lines of adequate therapy prior to enrolment, including at least one line consisting
of immunotherapy and/or chemotherapy and/or radiotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status
Additional criteria for prolonged maintenance (Maintenance II):

- Completed MabThera/Rituxan-based Induction and initial 2-year maintenance
(Maintenance I) therapy with sc MabThera/Rituxan

- Partial response or complete response after Maintenance I

Exclusion Criteria:

- Transformation to high-grade lymphoma

- Aggressive lymphoma (e.g. mantle cell lymphoma)

- Presence or history of central nervous system (CNS) lymphomatous disease

- Other malignancy within 5 years prior to enrolment, except for curatively treated
carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell
skin cancer, or cervical carcinoma stage 1B or less, breast cancer in situ or
localized prostate cancer stage T1c if treated with curative intent and relapse- and
metastasis-free for at least 2 years prior to enrolment

- Inadequate hematological, hepatic or renal function

- Positive for HIV infection

- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic
infections, active hepatitis B or C)

- Pregnant or breastfeeding women

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival (Maintenance II phase): from randomization to disease progression or death; tumour assessments according to the revised International Working Group response (Cheson) criteria for lymphoma

Outcome Time Frame:

approximately 24 months

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


Italy: Ministry of Health

Study ID:




Start Date:

December 2011

Completion Date:

July 2018

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin