Clinical trial · Interventional
Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)
A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
NCT01068392CI-TRIAL-00015979completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphomas | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, Prednisolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OXP
- description
- Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2HR D1 Prednisolone 100mg/Day D1-D5 Every 3 weeks Maximum 6 cycles of treatment will be given for this study. Subjects will be treated for at least 1 cycle and to a maximum of 6 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.
- interventionNames
- Drug: Oxaliplatin, Prednisolone
Primary outcomes (1)
- measure
- Response rate by International Working Group Response Criteria
- timeFrame
- 6 month after treatment
Secondary outcomes (2)
- measure
- progression free survival
- timeFrame
- 3 year after start
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOh SY, Kim WS, Kim JS, Chae YS, Lee GW, Eom HS, Ryoo HM, Lee S, Kim SJ, Yoon DH, Won JH, Hong J, Park J, Lee SM, Hong JY, Park E, Kim HJ, Yang DH, Kim HJ, Suh C. A phase II study of oxaliplatin and prednisone for patients with relapsed or refractory marginal zone lymphoma: Consortium for Improving Survival of Lymphoma trial. Leuk Lymphoma. 2016;57(6):1406-12. doi: 10.3109/10428194.2015.1099650. Epub 2015 Nov 16. PMID 26413982