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Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies
This study is currently recruiting participants.
Verified by Mayo Clinic, January 2006
First Received: January 10, 2006   No Changes Posted
Sponsors and Collaborators: Mayo Clinic
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Marrow Donor Program
University of Minnesota
University of Florida
Duke University
Children's Memorial Hospital
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275678
  Purpose

This study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation or with those who have had bone marrow transplantation from an unrelated donor for the treatment of serious hematological malignancies.


Condition Intervention Phase
Blood Stem Cell Transplant
Procedure: Blood stem cell versus bone marrow transplant
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From HLA Compatible Unrelated Donors.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Two-year survival from the time of randomization.

Secondary Outcome Measures:
  • Two-year survival
  • Neutrophil Engraftment > 500/mcl
  • Primary graft failure
  • Platelet engraftment > 20,000 and 50,000/mcl transfusion independent
  • Acute GVHD of grades II-IV and III-IV

Estimated Enrollment: 15
Study Start Date: November 2003
Detailed Description:

This study is a randomized, open-label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses marrow from unrelated donors for transplantation in patients with hematologic malignancies. The study will be comparing two-year survival probabilities between process has many steps after a matched donor is found. The donor also needs to give permission to join this study. Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow. The kind of transplant the participant receives is random. Neither the participant nor the doctor may choose the type of transplant. Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and pneumococcus. Blood samples will be drawn as part of a participant's normal care. Blood samples will also be collected to see if infection fighting cells are working. These samples will be collected at 12 weeks, one year and then yearly until three years post transplant. Information will be collected from the participant's medical history. Participants will also have phone interviews conducted and questions will be asked about their physical and emotional health.

Participants taking part in this study may be followed for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Criteria

Participants may be eligible if they are between the ages of 18 to 66 years and are undergoing unrelated blood stem cell transplantation for the first time for the treatment of their hematological malignancy. Additional eligibility criteria will be gathered and evaluated by the transplant physician to determine if an individual is eligible to take part.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275678

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennie A Wilson     507-284-6814        
Principal Investigator: Shakila P Khan, M.D.            
Sponsors and Collaborators
Mayo Clinic
National Marrow Donor Program
University of Minnesota
University of Florida
Duke University
Children's Memorial Hospital
Investigators
Principal Investigator: Shakila P. Khan, M.D. Mayo Clinic
  More Information

No publications provided

Study ID Numbers: 2158-03
Study First Received: January 10, 2006
Last Updated: January 10, 2006
ClinicalTrials.gov Identifier: NCT00275678     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 02, 2009