Bone Marrow Transplant Chart Review for RIC

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT00723333

Collaborator

Fred Hutchinson Cancer Center (Other), Baylor College of Medicine (Other), M.D. Anderson Cancer Center (Other)

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Myelofibrosis	Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant

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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030
2	M.D. Anderson Cancer Centers	Houston	Texas	United States	77030
3	University of Utah	Salt Lake City	Utah	United States	84132
4	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109