NCT01904175

Brief Summary

Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The investigators and others have shown that less toxic preparative regimens (reduced intensity or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions, significantly broadening the population of patients who may be offered this therapy to those who are older and more infirmed. The field is now focusing on the period post transplant for approaches to immune recovery leading to improved outcomes. The primary objective of this registry is to catalogue data from patients who undergo standard of care reduced intensity allogeneic transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

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

First Submitted

Initial submission to the registry

December 5, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

December 5, 2012

Last Update Submit

May 3, 2016

Conditions

Hodgkin's DiseaseNon Hodgkin's LymphomaMyelomaLeukemiaMyelodysplasia

Keywords

Stem cell transplantation, non-myeloablative

Outcome Measures

Primary Outcomes (1)

  • Catalogue Data

    Catalogue data from subjects who undergo standard of care reduced intensity allogeneic transplantation.

    1 year

Study Arms (1)

Reduced Intensity Allogeneic Transplant

Subjects undergoing a reduced intensity allogeneic stem cell transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic stem cell transplant

You may qualify if:

  • Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic transplant

You may not qualify if:

  • Subjects \< 18 years of age
  • Subjects not undergoing nonmyeloablative or ablative allogeneic transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-HodgkinNeoplasms, Plasma CellLeukemiaAnemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesAnemia, RefractoryAnemiaMyelodysplastic SyndromesBone Marrow Diseases

Study Officials

  • David Rizzieri, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2012

First Posted

July 22, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

US(1)