NCT00723333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

July 24, 2008

Last Update Submit

October 8, 2009

Conditions

Myelofibrosis

Keywords

Bone Marrow TransplantMyelofibrosisStem Cell TransplantAllogenic Transplant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Affected Group

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

Procedure: Reduced Intensity Conditioning (RIC) Allogenic Transplant

Interventions

Reduced Intensity Conditioning (RIC) Allogenic TransplantPROCEDURE

Reduced Intensity Conditioning (RIC) Regimen Allogenic Stem Cell Transplant

Also known as: Stem Cell Transplants, Bone Marrow Transplants, Mini Transplants
Affected Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Any subjects not meeting the criteria above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

M.D. Anderson Cancer Centers

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (3)

  • Hoffman R, Rondelli D. Biology and treatment of primary myelofibrosis. Hematology Am Soc Hematol Educ Program. 2007:346-54. doi: 10.1182/asheducation-2007.1.346.

    PMID: 18024650BACKGROUND

  • Mesa RA, Silverstein MN, Jacobsen SJ, Wollan PC, Tefferi A. Population-based incidence and survival figures in essential thrombocythemia and agnogenic myeloid metaplasia: an Olmsted County Study, 1976-1995. Am J Hematol. 1999 May;61(1):10-5. doi: 10.1002/(sici)1096-8652(199905)61:13.0.co;2-i.

    PMID: 10331505BACKGROUND

  • Rondelli D, Barosi G, Bacigalupo A, Prchal JT, Popat U, Alessandrino EP, Spivak JL, Smith BD, Klingemann HG, Fruchtman S, Hoffman R; Myeloproliferative Diseases-Research Consortium. Allogeneic hematopoietic stem-cell transplantation with reduced-intensity conditioning in intermediate- or high-risk patients with myelofibrosis with myeloid metaplasia. Blood. 2005 May 15;105(10):4115-9. doi: 10.1182/blood-2004-11-4299. Epub 2005 Jan 25.

    PMID: 15671439BACKGROUND

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Josef T Prchal, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

US(4)