NCT01095874

Completed

Allogeneic Hematopoietic Stem Cell Transplantation Evaluatio...

Saint-Louis Hospital, Paris, France Source

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Other study identifiers

Sponsor study identifier

AGRAAH 08-01

Study Type

observational

Actual enrollment (reported)

164

Locations

1 country

Sites

1

Timeline

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Actual (reported)

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 164 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 29, 2010
Actual (reported)
First Posted
March 30, 2010
Actual (reported)
Primary Completion
January 2014
Actual (reported)

Last Updated: January 20, 2014
Status Verified: January 2014
Last Update Submitted: 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

Sponsors & Collaborators

Saint-Louis Hospital, Paris, France
Otherlead
Hospital Avicenne
Othercollaborator
University Hospital, Grenoble

Study Sites (1)

Hôpital Saint-Louis

Paris, 75475, France

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Enrollment

164 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

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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.

Othercollaborator

University Hospital, Clermont-Ferrand

Othercollaborator

Primary Completion

January 2014

Actual (reported)

Last Updated

January 20, 2014

Record last verified: 2014-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01095874
Data provider: ClinicalTrials.gov
Source updated: 2014-01-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:27 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations