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

B-cell Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068392
• Other study ID #: CISL-MZL-10-3
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2010
• Last updated: November 2, 2014
• Start date: October 2009
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Dong-A University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• B-cell Lymphomas
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone

Intervention

Drug:
• Oxaliplatin, Prednisolone
OXALIPLATIN+PREDNISOLONE (OX-P) D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr D1-5 Prednisolone 40-30-30 mg/day P.O every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan

Sponsors (8)

Lead Sponsor	Collaborator
Dong-A University Hospital	Asan Medical Center, Chonnam National University Hospital, Chung-Ang University, Korea Cancer Center Hospital, Korea University, Kyungpook National University, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate by International Working Group Response Criteria		6 month after treatment	No
Secondary	progression free survival		3 year after start	No
Secondary	overall survival		5 year after start	No