NCT00336583

Brief Summary

Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 22, 2010

Completed
Last Updated

June 26, 2018

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

June 13, 2006

Results QC Date

May 5, 2009

Last Update Submit

March 19, 2018

Conditions

Non-Hodgkin's Lymphoma

Keywords

oxaliplatinESHAOXrefractoryrelapsednon-hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.

    up to 24 weeks

Secondary Outcomes (1)

  • Worst Toxicity Grade by Patient

    up to 24 weeks

Study Arms (1)

Oxaliplatin, response

EXPERIMENTAL

relapsed or refractory non-Hodgkin's lymphoma

Drug: Oxaliplatin

Interventions

OxaliplatinDRUG

Oxaliplatin, 130 mg per square meter, on day 1

Also known as: etoposide, 40 mg per square meter on days 1 to 4,, methylprednisolone, 500 mg on days 1 to 5,, cytarabine, 2 g per square meter on day 5
Oxaliplatin, response

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)
  • Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
  • Performance status (ECOG) ≤3
  • Age ≤ 75
  • Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen
  • At least one or more uni-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 organ functions defined as; ANC \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 X upper normal values; bilirubin \< 2 mg%
  • Written informed consent approved by Institutional Review Board

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Sym SJ, Lee DH, Kang HJ, Nam SH, Kim HY, Kim SJ, Eom HS, Kim WS, Suh C. A multicenter phase II trial of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin for patients with primary refractory/relapsed aggressive non-Hodgkin's lymphoma. Cancer Chemother Pharmacol. 2009 Jun;64(1):27-33. doi: 10.1007/s00280-008-0847-y. Epub 2008 Oct 7.

    PMID: 18839172RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinRecurrence

Interventions

OxaliplatinEtoposideMethylprednisoloneCytarabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Cheolwon Suh
Organization
Asan Medical Center
csuh@amc.seoul.kr
82 2 3010 3209

Study Officials

  • Cheolwon Suh, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2006

Study Completion

January 1, 2008

Last Updated

June 26, 2018

Results First Posted

June 22, 2010

Record last verified: 2009-09

Locations

KR(1)