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High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186394
First Posted: September 16, 2005
Last Update Posted: July 27, 2010
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Stanford University
  Purpose
To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.

Condition Intervention Phase
Lymphoma, Non-Hodgkin Blood and Marrow Transplant (BMT) Lymphomas: Non-Hodgkin Procedure: ablative allogeneic hematopoietic cell transplantation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety
  • Toxicity
  • Efficacy

Secondary Outcome Measures:
  • Incidence of acute and chronic GVHD

Estimated Enrollment: 35
Study Start Date: April 2000
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:
To determine safety and toxicity of a regimen of high dose chemotherapy with allogeneic peripheral blood progenitor cell transplantation; determine the efficacy of the procedure by following clinical outcomes and quality of life measures; and evaluate graft versus host disease incidence and severity with regimen.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Morphologically confirmed relapsed non-Hodgkin's lymphoma

Age: >18 and <61 years of age

Signed informed consent

Exclusion Criteria:Hepatic dysfunction defined by serum transaminases >2.5X normal values

Serum creatinine of > 2 mg/dl or creatinine clearance < 60 ml/min

Diseases other than non-Hodgkin's lymphoma

Prior bone marrow transplant procedure

Severe psychological or medical illness

  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): NCT00186394


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Wen-Kai Weng Stanford University
  More Information

Responsible Party: Wen-Kai Weng, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186394     History of Changes
Other Study ID Numbers: BMT4L
76679
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: July 27, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases