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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Cooperative Study Group A for Hematology

ClinicalTrials.gov Identifier:

NCT00561301

First received: November 18, 2007

Last updated: NA

Last verified: November 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 18, 2007

Last Updated Date

November 18, 2007

Start Date ^ICMJE

November 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

objective response rate [ Time Frame: 10/2009 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT [ Time Frame: 10/2009 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Drug: GemDOx

gemcitabine oxliplatin

Study Arm (s)

No Intervention: 1

Intervention: Drug: GemDOx

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yae Eun Jang

82-2-3010-7290

redpin75@paran.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00561301

Other Study ID Numbers ^ICMJE

C-012A

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cooperative Study Group A for Hematology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hawk Kim, professor

Ulsan Universtity Hospital, ROK

Information Provided By

Cooperative Study Group A for Hematology

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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