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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ablative allogeneic hematopoietic cell transplantation

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Outcomes

Primary Outcome Measures

Safety

Toxicity

Efficacy

Secondary Outcome Measures

Incidence of acute and chronic GVHD

Full Information

NCT ID

NCT00186394

First Posted

September 13, 2005

Last Updated

July 23, 2010

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT00186394

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

April 2000 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

ablative allogeneic hematopoietic cell transplantation

Primary Outcome Measure Information:

Title

Safety

Title

Toxicity

Title

Efficacy

Secondary Outcome Measure Information:

Title

Incidence of acute and chronic GVHD

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

61 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wen-Kai Weng

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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