Know Cancer

forgot password

A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Phase 2
20 Years
Open (Enrolling)
B-cell Lymphomas

Thank you

Trial Information

A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

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.

Inclusion Criteria:

- Histologically confirmed marginal zone B-cell lymphomas

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

- 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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate by International Working Group Response Criteria

Outcome Time Frame:

6 month after treatment

Safety Issue:


Principal Investigator

Cheolwon Suh, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

September 2014

Related Keywords:

  • B-Cell Lymphomas
  • relapsed
  • marginal zone B-cell lymphoma
  • oxaliplatin
  • prednisolone
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone