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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186394
First received: September 13, 2005
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute and chronic GVHD [ Time Frame: unknown ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wen-Kai Weng, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186394     History of Changes
Other Study ID Numbers: BMT4L, 76679, BMT4L
Study First Received: September 13, 2005
Last Updated: July 23, 2010
Health Authority: USA:IRB

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

ClinicalTrials.gov processed this record on June 18, 2013