Bone Marrow Transplant Chart Review for RIC

This study has been completed.
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Baylor College of Medicine
M.D. Anderson Cancer Center
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00723333
First received: July 24, 2008
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

We will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls.


Condition Intervention
Myelofibrosis
Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chart Review of Reduced Intensity Conditioning (RIC) Allogeneic Transplants in Elderly Patients With Myelofibrosis.

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Evaluation of engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. Data will be compared to appropriate historical controls. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Affected Group
Patients > 60 years of age with Primary Myelofibrosis that have undergone an allogeneic transplant
Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant
Reduced Intensity Conditioning (RIC) Regimen Allogenic Stem Cell Transplant
Other Names:
  • Stem Cell Transplants
  • Bone Marrow Transplants
  • Mini Transplants

Detailed Description:

Primary myelofibrosis (PMF) is among the Philadelphia Chromosome Negative Myeloproliferative Disorders. This diagnosis can be present at a patient's initial diagnosis or it can arise out of preceding Polycythemia Vera or Essential Thrombocythemia. While the clinical course is variable, it is defined by varying degrees of splenomegaly, anemia, fatigue and other constitutional symptoms. Patients with PMF are at increased risk of acute leukemia, bone marrow failure and thrombosis. Currently, the only curative treatment for PMF is allogeneic stem cell transplant. However, as the median age at diagnosis is in the mid to late 60s, most patients are no longer candidates for transplant due to their age and/or other comorbid illnesses.

Unfortunately, all other treatments for PMF are palliative in nature and often of limited efficacy. Over the last several years, many advances have occurred that have increased the safety and improved the outcomes of allogeneic transplants. Perhaps most important has been the ongoing refinement of reduced intensity conditioning (RIC) regimens prior to transplant. Over the last few years, many groups have published data suggesting that these RIC transplants can be very effective in the treatment of PMF and it is felt to be a potentially curative procedure. However, the vast majority of these data are reported in persons younger than 65 years old. The current protocol for RIC transplant for PMF available at the University of Utah excludes patients older than the age of 65.

We would like to see if there is sufficient successful experience with transplant in persons older than 60 years old (including many older than 65 years of age) to justify the creation of a clinical trial using RIC regimens in this older age group. We will be reviewing the medical records of approximately 30 patients at four different institutions:

  • University of Utah/Huntsman Cancer Hospital
  • Fred Hutchinson Cancer Research Center
  • Baylor College of Medicine
  • M.D. Anderson Cancer Centers

We will evaluate: engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls. We hypothesize that RIC regimens may be justifiably safe in older patients with PMF and hope that our data will allow the development of a corollary clinical trial.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients > 60 years of age with Primary Myelofibrosis that have undergone an allogeneic transplant

Criteria

Inclusion Criteria:

  • > 60 years of age
  • Diagnosed with Primary Myelofibrosis
  • Undergone Allogeneic Transplant

Exclusion Criteria:

  • Any subjects not meeting the criteria above
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723333

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
M.D. Anderson Cancer Centers
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Utah
Fred Hutchinson Cancer Research Center
Baylor College of Medicine
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Josef T Prchal, MD University of Utah
  More Information

Publications:
Responsible Party: Josef T. Prchal, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00723333     History of Changes
Other Study ID Numbers: 29021
Study First Received: July 24, 2008
Last Updated: October 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Bone Marrow Transplant
Myelofibrosis
Stem Cell Transplant
Allogenic Transplant

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014