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Chart Review of Reduced Intensity Conditioning (RIC) Allogeneic Transplants in Elderly Patients With Myelofibrosis.


N/A
60 Years
N/A
Not Enrolling
Both
Myelofibrosis

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Trial Information

Chart Review of Reduced Intensity Conditioning (RIC) Allogeneic Transplants in Elderly Patients With Myelofibrosis.


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.


Inclusion Criteria:



- > 60 years of age

- Diagnosed with Primary Myelofibrosis

- Undergone Allogeneic Transplant

Exclusion Criteria:

- Any subjects not meeting the criteria above

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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.

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Josef T Prchal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Institutional Review Board

Study ID:

29021

NCT ID:

NCT00723333

Start Date:

May 2008

Completion Date:

July 2009

Related Keywords:

  • Myelofibrosis
  • Bone Marrow Transplant
  • Myelofibrosis
  • Stem Cell Transplant
  • Allogenic Transplant
  • Primary Myelofibrosis

Name

Location

Baylor College of MedicineHouston, Texas  77030
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of UtahSalt Lake City, Utah  
M.D. Anderson Cancer CentersHouston, Texas  77030