NCT01068392

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3.9 years

First QC Date

February 11, 2010

Last Update Submit

November 2, 2014

Conditions

B-cell Lymphomas

Keywords

relapsedmarginal zone B-cell lymphomaoxaliplatinprednisolone

Outcome Measures

Primary Outcomes (1)

  • Response rate by International Working Group Response Criteria

    6 month after treatment

Secondary Outcomes (2)

  • progression free survival

    3 year after start

  • overall survival

    5 year after start

Study Arms (1)

OXP

EXPERIMENTAL

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

Interventions

Oxaliplatin, PrednisoloneDRUG

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

OXP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Related Publications (1)

  • Oh 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: 26413982DERIVED

MeSH Terms

Conditions

Lymphoma, B-CellRecurrenceLymphoma, B-Cell, Marginal Zone

Interventions

OxaliplatinPrednisolone

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Cheolwon Suh, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Sung Yong Oh, M.D., Ph.D.

    Dong-A University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of internal medicine

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

KR(1)