Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A University Hospital
• Collaborators: Asan Medical Center; Chonnam National University Hospital; Chung-Ang University; Korea Cancer Center Hospital; Korea University; Kyungpook National University; Kyungpook National University Hospital; Samsung Medical Center
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Oxaliplatin; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Histologically confirmed marginal zone B-cell lymphomas

• Failure to achieve a clinical benefit (≥SD) with the initial treatment, or recurrent disease

• Performance status (ECOG) ≤2

• Age ≥ 20

• At least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination

• Adequate kidney functions defined as; Cr < 2.0 mg% or Ccr > 60 ml/min

• Adequate liver functions defined as; Transaminases < 3 X upper normal values; Bilirubin < 2 mg%

• Adequate bone marrow functions defined as; ANC > 1500/㎕, platelet > 75000/㎕

• Ann Arbor stage III or IV

• Ann Arbor stage I or II, which is not adequate for RT or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal LN with stomach involvement)

• Written informed consent approved by Institutional review board or Ethic committee

Exclusion Criteria:

• Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix

• Serious co-morbid diseases

• Pregnancy or breast feeding

• Previous history of drug allergy to one of the drugs in the study regimen

• During this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy