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R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma

Phase 2
20 Years
Open (Enrolling)

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Trial Information

R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma

no desire description

Inclusion Criteria:

- Histologically confirmed CD20 positive marginal zone B-cell lymphomas

- Ann Arbor stage III or IV

- No prior chemotherapy or radiotherapy for advanced stage MZL

- Tumor response after 8th cycles of R-CVP CTx ≥ SD (Stable disease)

- Performance status (ECOG) ≤ 2

- age ≥ 20

- At least one or more bidimensionally measurable lesion(s): ≥ 2 cm by conventional CT/
≥ 1 cm by spiral CT/ skin lesion (photographs should be taken) ≥ 2 cm/ measurable
lesion by physical examination ≥ 2 cm

- Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)

- Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value /
Bilirubin < 1.5 X upper normal value /Alkaline phosphatase < 5 X upper normal value

- Adequate BM functions:ANC > 1500/uL and platelet > 75,000/uL and Hemoglobin > 9.0
g/dL unless abnormalities are due to bone marrow involvement by lymphoma

- Informed consent

Exclusion Criteria:

- Other subtypes NHL than MZL

- Large cell component >10%

- Tumor response after 8th cycles CTx = PD (Progression disease)

- Central nervous system (CNS) metastasis

- Any other malignancies within the past 5 years except curatively treated non-melanoma
skin cancer or in situ carcinoma of cervix uteri

- Pregnant or lactating women, women of childbearing potential not employing adequate

- Other serious illness or medical conditions i. Unstable cardiac disease despite
treatment, myocardial infarction within 6 months prior to study entry ii. History of
significant neurologic or psychiatric disorders including dementia or seizures iii.
Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other
serious medical illnesses

- Known hypersensitivity to any of the study drugs or its ingredients (i.e.,
hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human

- Concomitant administration of any other experimental drug under investigation, or
concomitant chemotherapy, hormonal therapy, or immunotherapy.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 year progression free survival

Outcome Description:

Historic 3 year progression free survival rate was 60 %, expected difference 20%, power 0.80, significance 0.05 and drop rate=0.1.

Outcome Time Frame:

3 years after last patient enrollment

Safety Issue:


Principal Investigator

Sung Yong Oh, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Dong-A University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

September 2015

Related Keywords:

  • Lymphoma
  • Lymphoma
  • B-Cell
  • Marginal Zone
  • Rituximab
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone