R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)

May 3, 2021 updated by: Sung-Yong Kim, Konkuk University Medical Center

Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma

The purpose of this study is to determine how efficient the combination of rituximab, cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II non-conjunctival ocular adnexal MALT lymphoma (OAML).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The treatment of stage I or II OAML is mainly composed of radiotherapy because chemotherapy including cyclophosphamide, vincristine, and prednisolone (CVP) did not show the acceptable response rate compared with radiotherapy. However, radiotherapy for this disease can cause many complications of eyes. This clinical trial was designed to examine the efficacy of R-CVP combination therapy as a first-line treatment for stage I or II non-conjunctival OAML aiming to avoid radiation hazard and increase the efficacy of CVP chemotherapy.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 137-701
        • Seoul st. mary's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed OAML
  • Non-conjunctival or bilateral conjunctival (TNM-based, above T1N0M0 or bT1N0M0), Ann Arbor stage I and II OAML
  • Previously untreated
  • Age ≥18 years
  • Performance status: ECOG 0-2
  • Adequate hematological function: hemoglobin ≥9 g/dL,, absolute neutrophil count (ANC) ≥1,500/μL, and platelet count ≥100,000/μL, unless abnormalities are due to bone marrow involvement by the lymphoma

  • Adequate liver function tests:

    i. Transaminase (AST/ALT) <3 times the upper normal value ii. Bilirubin <2 times the upper normal value

  • Adequate renal function:serum creatinine level <2 mg/dL (177 μmol/L)
  • Life expectancy ≥ 6 months
  • A negative serum or urine pregnancy test before treatment must be available for both premenopausal women and for women who have <2 years after the onset of menopause.
  • Informed consent

Exclusion Criteria:

  • NHL subtypes other than OAML
  • Primary conjunctival OAML, unilateral involved (T1N0M0)
  • Ann Arbor stage III or IV
  • CNS involvement by the lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) with clinical suspicion of CNS involvement by the lymphoma
  • Pregnant or lactating women, women of child-bearing potential not using adequate contraception

  • Inadequate liver function tests:

    i. Transaminase (AST/ALT) ≥3 times the upper normal value or ii. Bilirubin ≥2 times the upper normal value

  • Inadequate renal function:

    i. serum creatinine level <2 mg/dL (177 μmol/L)

  • 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 neurological or psychiatric disorders including dementia or seizures
  • Active uncontrolled infection (HIV, hepatitis B, Hepatitis C, active Tuberculosis, active bacterial, or active fungal infection)
  • Any other malignancies within the past 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: R-CVP
6 cycles of R-CVP followed by 2 cycles of rituximab
Drug: rituximab, cyclophosphamide, vincristine, and prednisolone
6 cycles of R-CVP followed by 2 cycles of rituximab
Other Names:
  • 6 cycles of R-CVP followed by 2 cycles of rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response rate
Time Frame: 3 years
CR rate
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival
5 years
Progression free survival
Time Frame: 5 years
Progression free survival
5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Collaborators

Seoul St. Mary's Hospital

Investigators

  • Principal Investigator: Seok-Goo Cho, Ph.D., Seoul st. mary's hospital
  • Principal Investigator: Sung-Yong Kim, Ph.D., Konkuk University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2011

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (ESTIMATE)

September 1, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1010258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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