Evaluating the Safety of G-CSF Mobilization in Individuals With Beta Thalassemia Major

Plain-language summary

This study evaluates the safety of G-CSF mobilization, a procedure to move stem cells into the bloodstream, in individuals with beta thalassemia major. The study used hydroxyurea, and patients with beta thalassemia major who were compliant with regular transfusions and chelation therapy were able to take part. Sponsored by the University of Washington, this study had no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Washington

Intervention

Hydroxyurea

Start date

7/1/2006

Estimated completion

8/1/2010

Countries

Greece

Related genes

Locations

• Thessaloniki, Greece

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* β-thalassemia major
* Karnofsky performance status greater than or equal to 80%
* Splenectomized patients or patients with spleen volume less than 800 cm\^3 (V=0.523 x length x thickness x width)
* Compliant with regular transfusions and regular chelation
* Liver iron by magnetic resonance imaging (MRI) less than 280 μmol/gr or greater than or equal to 1.7 msec by T2\*MRI
* Heart iron by MRI greater than 2.8 (SI/SD)or greater than or equal to 9 msec by T2\*MRI
* Hepatitis B or C virus load negative by polymerase chain reaction (PCR)
* Left ventricular ejection fraction (LVEF) greater than 45% by echocardiogram or multiple gated acquisition scan (MUGA)
* Adequate respiratory function with diffusing capacity of the lung for carbon monoxide (DLCO) greater than 50%
* Negative pregnancy test, if female
* Ability to give informed consent and willingness to meet all the expected requirements of the protocol for the duration of the study

Exclusion Criteria:

* History of thrombosis or known thrombophilia
* Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility evaluation
* Pregnant or breastfeeding
* HIV positivity
* History of cancer, other than local skin cancer
* Other systematic disease
* Splenectomized patients with platelet count greater than 900,000
* Additional risk factors for thrombosis, including Factor V Leiden; antiphospholipid antibodies; and less than 50% of the lowest normal value for the following procoagulants: antithrombin 3, protein C, or protein S