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

NCT ID: NCT01427114

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-01
• Study Completion Date: 2021-01-01

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).

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CVP

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

Group Type: EXPERIMENTAL

rituximab, cyclophosphamide, vincristine, and prednisolone

Intervention Type: DRUG

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

Interventions

rituximab, cyclophosphamide, vincristine, and prednisolone

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

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: collaborator

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Yong Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seok-Goo Cho, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Sung-Yong Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Seoul St. Mary's Hospital

Seoul, , South Korea

KonKuk University Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28978139 (View on PubMed)

Other Identifiers

KUH1010258

Identifier Type: -

Identifier Source: org_study_id