Bone Marrow Transplant Chart Review for RIC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myelofibrosis

Intervention / Treatment
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* Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 60 years of age Diagnosed with Primary Myelofibrosis Undergone Allogeneic Transplant Exclusion Criteria: Any subjects not meeting the criteria above

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected Group<br>Patients > 60 years of age with Primary Myelofibrosis that have undergone an allogeneic transplant | Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant<br>* Reduced Intensity Conditioning (RIC) Regimen Allogenic Stem Cell Transplant<br>* Other names: Mini Transplants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Transplant, Myelofibrosis, Stem Cell Transplant, Allogenic Transplant