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

NCT01427114 | Completed Phase 2

• 1 other identifier: KUH1010258
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Lymphoma

Keywords

extranodal marginal zone lymphoma; ocular adnexal lymphoma; mucosa associated lymphoid tissue; cyclophosphamide; vincristine; prednisolone

Outcome Measures

Primary Outcomes (1)

• complete response rate

  CR rate

  3 years

Secondary Outcomes (3)

• Progression free survival

  5 years

• Overall survival

  5 years

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  5 years

Study Arms (1)

R-CVP

EXPERIMENTAL

6 cycles of R-CVP followed by 2 cycles of rituximab

Drug: rituximab, cyclophosphamide, vincristine, and prednisolone

Interventions

rituximab, cyclophosphamide, vincristine, and prednisolone DRUG

6 cycles of R-CVP followed by 2 cycles of rituximab

Also known as: 6 cycles of R-CVP followed by 2 cycles of rituximab

R-CVP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• Seoul St. Mary's Hospital: collaborator

Study Sites (2)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

KonKuk University Medical Center

Seoul, 143-729, South Korea

Location

Related Publications (1)

• Kim SY, Yang SW, Lee WS, Yang JW, Oh SY, Ahn HB, Yang DH, Park SK, Chang JH, Kim HJ, Lee MJ, Cho SG. Frontline treatment with chemoimmunotherapy for limited-stage ocular adnexal MALT lymphoma with adverse factors: a phase II study. Oncotarget. 2017 Aug 2;8(40):68583-68590. doi: 10.18632/oncotarget.19788. eCollection 2017 Sep 15.

  PMID: 28978139 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab; Cyclophosphamide; Vincristine; Prednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Seok-Goo Cho, Ph.D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sung-Yong Kim, Ph.D.

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

KR (2)