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Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

NCT ID: NCT00561301

Last Updated: 2007-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-10-31

Brief Summary

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

Detailed Description

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\- The feasibility will be evaluated in terms of objective response rate, efficacy of stem cell collection, disease-free survival, and overall survival.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

GemDOx

Intervention Type DRUG

gemcitabine oxliplatin

Interventions

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GemDOx

gemcitabine oxliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients who have received GEM or OX
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Study Group A for Hematology

NETWORK

Sponsor Role lead

Principal Investigators

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Hawk Kim, professor

Role: PRINCIPAL_INVESTIGATOR

Ulsan Universtity Hospital, ROK

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yae Eun Jang

Role: CONTACT

Phone: 82-2-3010-7290

Email: [email protected]

Facility Contacts

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Yae-Eun Jang, nurse

Role: primary

Other Identifiers

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C-012A

Identifier Type: -

Identifier Source: org_study_id