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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186394
First received: September 13, 2005
Last updated: July 23, 2010
Last verified: July 2010
  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:


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
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 ClinicalTrials.gov identifier: NCT00186394

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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 July 22, 2014