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

This study is currently recruiting participants.

Verified by Cooperative Study Group A for Hematology, November 2007

Sponsored by:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT00561301

Purpose

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

Condition	Intervention	Phase
Lymphoma	Drug: GemDOx	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Gemcitabine hydrochloride Gemcitabine Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:

objective response rate [ Time Frame: 10/2009 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	43
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: No Intervention	Drug: GemDOx gemcitabine oxliplatin

Detailed Description:

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

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561301

Contacts

Contact: Yae Eun Jang

82-2-3010-7290

redpin75@paran.com

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Yae-Eun Jang, nurse 82-2-3010-7290 redpin75@naver.com

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:

Hawk Kim, professor

Ulsan Universtity Hospital, ROK

More Information

Study ID Numbers:	C-012A
Study First Received:	November 18, 2007
Last Updated:	November 18, 2007
ClinicalTrials.gov Identifier:	NCT00561301
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Lymphatic Diseases
Oxaliplatin
Immunoproliferative Disorders

Gemcitabine
Lymphoproliferative Disorders
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Neoplasms by Histologic Type

Immune System Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009