Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma|
- Response rate by International Working Group Response Criteria [ Time Frame: 6 month after treatment ] [ Designated as safety issue: No ]
- progression free survival [ Time Frame: 3 year after start ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 5 year after start ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
Drug: Oxaliplatin, Prednisolone
D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr
D1-5 Prednisolone 40-30-30 mg/day P.O
every 3 weeks
Over its long survival duration, MZL often involves frequent relapses. Overall, more than 50% of MZL patients experience a relapse within 10 years. However, Relapsed or refractory MZL represent a therapeutic dilemma in every day clinical practice and no prospective studies on large series have been published so far. The rarity of these disorders and some difficulties in the differential diagnosis from other low-grade lymphoma subtypes are obstacles in conducting epidemiological surveys and in properly describing clinical features and outcomes.
Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful antitumor activity with favourable toxicity profile.
In the previous phase II study of oxaliplatin for treatment of patients with mucosa-associated lymphoid tissue lymphoma, a total of 16 patients with MALT lymphoma of various sites of origin (four of the ocular adnexa, five of the salivary glands, three of the stomach, two of the lung, and one of the colon and the breast) were administered oxaliplatin at a dose of 130 mg/m2 infused during 2 hours every 3 weeks. Fifteen patients responded to chemotherapy, with nine achieving CR (56%), six (37.5%) achieving partial response, and one achieving stable disease; the median time to response was 4 months (range; 2 to 4 months).
Based upon the promising results of oxaliplatin regimen in refractory NHL and first-line treatment of MZL, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068392
|Korea, Republic of|
|Dong-A University Hospital|
|Busan, Korea, Republic of, 602-715|
|Principal Investigator:||Cheolwon Suh, M.D., Ph.D.||Asan Medical Center|
|Study Director:||Sung Yong Oh, M.D., Ph.D.||Dong-A University|