We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

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.
 
ClinicalTrials.gov Identifier: NCT00186342
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Robert Negrin, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

Condition or disease Intervention/treatment Phase
Acute Disease Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Myeloproliferative Disorders Blood and Marrow Transplant (BMT) Myelodysplastic Syndromes (MDS) Leukemia Procedure: ablative allogeneic hematopoietic cell transplantation Not Applicable

Detailed Description:
To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
Study Start Date : September 1992
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CIK cell
The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.
 Procedure: ablative allogeneic hematopoietic cell transplantation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. tolerability
  2. efficacy of therapy

Secondary Outcome Measures :
  1. compare efficacy of this treatment to historical controls

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   51 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

2) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.

3) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.

4) Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00186342


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Robert S Negrin Stanford University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Robert Negrin, Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00186342    
Other Study ID Numbers: BMT45
75274
BMT45
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Preleukemia
Hematologic Neoplasms
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Acute Disease
 Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Disease Attributes