NCT00186576

Brief Summary

To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic hematopoietic cell transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 14, 2010

Status Verified

October 1, 2010

Enrollment Period

2.2 years

First QC Date

September 14, 2005

Last Update Submit

October 13, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy of transplant

    1 year

Secondary Outcomes (1)

  • safety profile of nonmyeloablative transplant, graft versus host disease, graft rejection, non-relapse mortality, use of donor lymphocyte infusion

    1 year

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myeloproliferative Disorders

You may not qualify if:

  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Laport GG, Sandmaier BM, Storer BE, Scott BL, Stuart MJ, Lange T, Maris MB, Agura ED, Chauncey TR, Wong RM, Forman SJ, Petersen FB, Wade JC, Epner E, Bruno B, Bethge WA, Curtin PT, Maloney DG, Blume KG, Storb RF. Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome and myeloproliferative disorders. Biol Blood Marrow Transplant. 2008 Feb;14(2):246-55. doi: 10.1016/j.bbmt.2007.11.012.

  • Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.

MeSH Terms

Conditions

Myelodysplastic SyndromesMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ginna Laport

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

December 1, 2001

Primary Completion

March 1, 2004

Study Completion

July 1, 2010

Last Updated

October 14, 2010

Record last verified: 2010-10

Locations