ClinicalTrials.gg
CompletedNCT01095874ONIalloMDSUpdated Jan 20, 2014

Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study

An observational study in Myelodysplasia, sponsored by Saint-Louis Hospital, Paris, France. Completed at 1 site in France. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-01-20.

Sponsored by Saint-Louis Hospital, Paris, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myelodysplasia

Keywords

  • myelodysplasia
  • allogeneic hematopoietic stem cell transplantation
  • Survival
  • Transplantation
03

In context

Lead sponsor

Saint-Louis Hospital, Paris, France is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 50 to 70 years
  • For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:

    1. IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
    2. thrombopenia \< 20x10ex9/L:
    3. IPSS intermediate 2 or high
  • For CMML: patients can be included if they have at least one of these criteria:

    1. 2 of these criteria: hyperleucocytosis > 10x10exp9/L, splenomegaly>18cm, \< 10gr/dl, \< 100x10ex9/L
    2. IPSS intermediate 2 or high

Exclusion criteria

Exclusion Criteria:

  • Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
  • Renal failure with \< 30ml/min
  • Cirrhosis or hepatic failure
  • Respiratory disease with vital capacity \< 30%
  • Uncontrolled cardiac failure
  • Uncontrolled neurological disease
  • Poor performance status with \< or = 60%
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (actual)
06

What researchers measure

Primary outcomes

  1. overall survival in patient with or without donor

    Time frame: 36 months

07

Study locations

1 site
  • Hôpital Saint-Louis
    Paris Cedex 10, 75475, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008 and a primary completion of Jan 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2010
First posted
Mar 30, 2010
Start
Jan 2008
Primary completionActual
Jan 2014
Last update
Jan 20, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01095874
Lead sponsor
Saint-Louis Hospital, Paris, France
Responsible party
Marie Robin (Dr Marie Robin, Saint-Louis Hospital, Paris, France) — Principal investigator
First posted
Mar 30, 2010
Start date
Jan 2008
Primary completion
Jan 2014
Last update
Jan 20, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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