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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Sung-Yong Kim, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01427114
First received: August 30, 2011
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Lymphoma
Drug: rituximab, cyclophosphamide, vincristine, and prednisolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • complete response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: July 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 6 cycles of R-CVP followed by 2 cycles of rituximab

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01427114

Locations
Korea, Republic of
KonKuk University Medical Center
Seoul, Korea, Republic of, 143-729
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Konkuk University Medical Center
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
  More Information

No publications provided

Responsible Party: Sung-Yong Kim, Assistant Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01427114     History of Changes
Other Study ID Numbers: KUH1010258
Study First Received: August 30, 2011
Last Updated: July 23, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Konkuk University Medical Center:
extranodal marginal zone lymphoma
ocular adnexal lymphoma
mucosa associated lymphoid tissue
cyclophosphamide
vincristine
prednisolone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Autonomic Agents

ClinicalTrials.gov processed this record on October 20, 2014