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

Tracking Information
First Submitted Date ICMJE	September 30, 2010
First Posted Date ICMJE	October 1, 2010
Last Update Posted Date	April 11, 2016
Study Start Date ICMJE	September 2010
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 30, 2010)	3 year progression free survival [ Time Frame: 3 years after last patient enrollment ]; Historic 3 year progression free survival rate was 60 %, expected difference 20%, power 0.80, significance 0.05 and drop rate=0.1.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01213095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 30, 2010)	Overall survival [ Time Frame: 5 years after last patients enrollment ]; toxicity [ Time Frame: during the Rituximab maintenance treatment ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Rituximab Maintenance Therapy for Marginal Zone B-cell Lymphoma (MZL)
Official Title ICMJE	R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma
Brief Summary	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.
Detailed Description	no desire description
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lymphoma
Intervention ICMJE	Drug: rituximab; rituximab 375mg/m2, every 8 weeks, 12 times
Study Arms	Experimental: Rituximab; rituximab 375mg/m2, every 8 weeks, 12 times; Intervention: Drug: rituximab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 7, 2016)	48
Original Estimated Enrollment ICMJE; (submitted: September 30, 2010)	39
Actual Study Completion Date	September 2015
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01213095
Other Study ID Numbers ICMJE	CISL-MZL-10-4(ML25403)
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sung Yong Oh, Dong-A University Hospital
Study Sponsor ICMJE	Dong-A University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Sung Yong Oh, M.D. Dong-A University Hospital
PRS Account	Dong-A University Hospital
Verification Date	November 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP