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
Information provided by:
Cooperative Study Group A for Hematology Identifier:
First received: November 18, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
- 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
Drug: GemDOx
Phase 2

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

Resource links provided by NLM:

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
No Intervention: 1 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.

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00561301     History of Changes
Other Study ID Numbers: C-012A 
Study First Received: November 18, 2007
Last Updated: November 18, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2016