NCT00561301

Brief Summary

\- To evaluate the feasibility of combination chemotherapies comprising of gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant non-Hodgkin lymphoma (NHL)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 18, 2007

Last Update Submit

November 18, 2007

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    10/2009

Secondary Outcomes (1)

  • toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT

    10/2009

Study Arms (1)

1

NO INTERVENTION
Drug: GemDOx

Interventions

GemDOxDRUG

gemcitabine oxliplatin

1

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have refractory to first-line CHOP-like regimen
  • Patients who have first relapse after
  • first-line CHOP-like regimen
  • upfront autologous or allogeneic hematopoietic stem cell transplantation
  • Age 15 years or more
  • ECOG performance status ≤ 2
  • Adequate bone marrow function
  • Adequate kidney,liver,cardiac

You may not qualify if:

  • Patients who have received GEM or OX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hawk Kim, professor

    Ulsan Universtity Hospital, ROK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yae Eun Jang

CONTACT

82-2-3010-7290redpin75@paran.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 18, 2007

First Posted

November 20, 2007

Study Start

November 1, 2006

Study Completion

October 1, 2009

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

KR(1)