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

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

rituximab

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, B-Cell, Marginal Zone, Rituximab

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sung Yong Oh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

rituximab 375mg/m2, every 8 weeks, 12 times

Outcomes

Primary Outcome Measures

3 year progression free survival

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

toxicity

Full Information

NCT ID

NCT01213095

First Posted

September 30, 2010

Last Updated

April 7, 2016

Sponsor

Dong-A University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01213095

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

Lymphoma, B-Cell, Marginal Zone, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab

Arm Type

Experimental

Arm Description

rituximab 375mg/m2, every 8 weeks, 12 times

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Description

rituximab 375mg/m2, every 8 weeks, 12 times

Primary Outcome Measure Information:

Title

3 year progression free survival

Description

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

Time Frame

3 years after last patient enrollment

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

5 years after last patients enrollment

Title

toxicity

Time Frame

during the Rituximab maintenance treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung Yong Oh, M.D.

Organizational Affiliation

Dong-A University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Sung Yong Oh

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31619290

Citation

Oh SY, Kim WS, Kim JS, Kim SJ, Yoon DH, Yang DH, Lee WS, Kim HJ, Yhim HY, Jeong SH, Won JH, Lee S, Kong JH, Lim SN, Ji JH, Kwon KA, Lee GW, Lee JH, Lee HS, Shin HJ, Suh C. Phase II study of R-CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study. Cancer Commun (Lond). 2019 Oct 16;39(1):58. doi: 10.1186/s40880-019-0403-7.

Results Reference

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

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