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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Seok-Goo Cho, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul St. Mary's Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

KUH1010258

NCT ID:

NCT01427114

Start Date:

July 2011

Completion Date:

August 2016

Related Keywords:

  • Lymphoma
  • extranodal marginal zone lymphoma
  • ocular adnexal lymphoma
  • mucosa associated lymphoid tissue
  • cyclophosphamide
  • vincristine
  • prednisolone
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

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