Rituximab Maintenance Therapy for Marginal Zone B-cell Lymphoma (MZL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Dong-A University Hospital
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital
ClinicalTrials.gov Identifier:
NCT01213095
First received: September 30, 2010
Last updated: May 5, 2012
Last verified: May 2012
  Purpose

The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but the use of this antibody has been extended over the last few years to the majority of subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus far. In MZL, small numbers of case reports have chronicled the use of rituximab as a single agent or phase II trial combination with chemotherapeutic regimens.

The results of the rituximab maintenance phase III trial demonstrated that patients with FL who continued to take rituximab monotherapy as a maintenance therapy after responding to an initial course of chemotherapy combined with or without rituximab experienced longer progression-free survival durations than did those who received no rituximab maintenance therapy. The efficacy of maintenance treatment after first-line induction treatment with R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance) study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although MZL has better prognosis in TTP and OS than FL, both of them are classified as the same category of indolent lymphoma -characterized by frequent relapse and prolonged survival.

According to the results of our survey, advanced stage MZL tends to be an indolent disease - characterized by prolonged survival with frequent relapses. Rituximab appears to contribute to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL patients, to extend their response duration.


Condition Intervention Phase
Lymphoma
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Dong-A University Hospital:

Primary Outcome Measures:
  • 3 year progression free survival [ Time Frame: 3 years after last patient enrollment ] [ Designated as safety issue: No ]
    Historic 3 year progression free survival rate was 60 %, expected difference 20%, power 0.80, significance 0.05 and drop rate=0.1.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years after last patients enrollment ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: during the Rituximab maintenance treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
rituximab 375mg/m2, every 8 weeks, 12 times
Drug: rituximab
rituximab 375mg/m2, every 8 weeks, 12 times

Detailed Description:

no desire description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 contraception
  • 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 antibodies)
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
  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: NCT01213095

Contacts
Contact: Sung Yong Oh, M.D. +82-51-240-2808 drosy@dau.ac.kr

Locations
Korea, Republic of
Sung Yong Oh Recruiting
Busan, Korea, Republic of, 602-715
Contact: Sung Yong Oh, M.D.    +82-51-240-2808    drosy@dau.ac.kr   
Sponsors and Collaborators
Dong-A University Hospital
Investigators
Study Director: Sung Yong Oh, M.D. Dong-A University Hospital
  More Information

No publications provided

Responsible Party: Sung Yong Oh, Department of internal medicine, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT01213095     History of Changes
Other Study ID Numbers: CISL-MZL-10-4(ML25403)
Study First Received: September 30, 2010
Last Updated: May 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong-A University Hospital:
Lymphoma
B-Cell
Marginal Zone
Rituximab

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

ClinicalTrials.gov processed this record on September 16, 2014