NCT01095874

Brief Summary

The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

6 years

First QC Date

March 29, 2010

Last Update Submit

January 17, 2014

Conditions

Myelodysplasia

Keywords

myelodysplasiaallogeneic hematopoietic stem cell transplantationSurvivalTransplantation

Outcome Measures

Primary Outcomes (1)

  • overall survival in patient with or without donor

    36 months

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation

You may qualify if:

  • to 70 years
  • For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:
  • IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
  • thrombopenia \< 20x10ex9/L:
  • IPSS intermediate 2 or high
  • For CMML: patients can be included if they have at least one of these criteria:
  • of these criteria: hyperleucocytosis \> 10x10exp9/L, splenomegaly\>18cm, hemoglobin \< 10gr/dl, platelet \< 100x10ex9/L
  • IPSS intermediate 2 or high

You may not qualify if:

  • Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
  • Renal failure with creatinine clearance \< 30ml/min
  • Cirrhosis or hepatic failure
  • Respiratory disease with vital capacity \< 30%
  • Uncontrolled cardiac failure
  • Uncontrolled neurological disease
  • Poor performance status with karnofsky \< or = 60%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint-Louis

Paris, 75475, France

Location

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Marie Robin

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

FR(1)