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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561301
First Posted: November 20, 2007
Last Update Posted: November 20, 2007
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.
Information provided by:
Cooperative Study Group A for Hematology
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00561301     History of Changes
Other Study ID Numbers: C-012A
First Submitted: November 18, 2007
First Posted: November 20, 2007
Last Update Posted: November 20, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Gemcitabine
Oxaliplatin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents