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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186394
• Other study ID #: BMT4L
• Secondary ID: 76679BMT4L
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 23, 2010
• Start date: April 2000
• Est. completion date: December 2006

Study information

• Verified date: July 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA:IRB
• Study type: Interventional

Clinical Trial Summary

To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 61 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood and Marrow Transplant (BMT)
• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphomas: Non-Hodgkin

Intervention

Procedure:
• ablative allogeneic hematopoietic cell transplantation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		unknown	Yes
Primary	Toxicity		unknown	Yes
Primary	Efficacy		unknown	No
Secondary	Incidence of acute and chronic GVHD		unknown	No