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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561301
Recruitment Status : Unknown
Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : November 20, 2007
Last Update Posted : November 20, 2007
Information provided by:
Cooperative Study Group A for Hematology

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)

Condition or disease Intervention/treatment Phase
Lymphoma Drug: GemDOx Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma
Study Start Date : November 2006
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
No Intervention: 1 Drug: GemDOx
gemcitabine oxliplatin

Primary Outcome Measures :
  1. objective response rate [ Time Frame: 10/2009 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561301

Contact: Yae Eun Jang 82-2-3010-7290

Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yae-Eun Jang, nurse    82-2-3010-7290   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Principal Investigator: Hawk Kim, professor Ulsan Universtity Hospital, ROK Identifier: NCT00561301     History of Changes
Other Study ID Numbers: C-012A
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors