EUCTR2009-014136-37-GR
Active, not recruiting
Not Applicable
A pilot study on the safety and efficacy of haemopoietic stem cell mobilization (CD34+ cells) with MOZOBIL ± G-CSF, in adult patients diagnosed with beta-thalassaemia major.
niversity of Washington0 sitesJune 15, 2010
ConditionsBeta-thalassaemia majorMedDRA version: 12.0Level: LLTClassification code 10004505Term: Beta thalassaemiaMedDRA version: 12.0Level: LLTClassification code 10004514Term: Beta-thalassaemiaMedDRA version: 12.0Level: LLTClassification code 10043391Term: Thalassaemia beta
DrugsMozobil
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Beta-thalassaemia major
- Sponsor
- niversity of Washington
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) ?eta\- thalassemia major
- •b) Age \>18\<50
- •c) Karnofsky performance status ³80%
- •d) Splenectomized patients or patients with spleen volume \<800cm3 (only for the non splenectomized patients
- •who will receive Mozobil \+ G\-CSF) \[V\=0\.523 x length x thickness x width (De Odorico I et al, 1999\)]
- •e) Compliant with regular transfusions and regular chelation
- •f) Liver iron by MRI \<280µmol/gr or 1\.7msec by T2\*MRI
- •g) Heart iron by MRI \>2\.8 (SI/SD) or 9msec by T2\*MRI
- •h) Hepatitis B or C virus load negative by PCR
- •i) Left ventricular ejection fraction (LVEF) \>45% by echocardiogram
Exclusion Criteria
- •a) History of thrombosis or known thrombophilia
- •b) Symptomatic viral, bacterial or fungal infection within 6 weeks prior eligibility evaluation
- •c) Pregnancy or lactation
- •d) HIV positivity
- •e) History of malignancy, other than local skin cancer
- •f) Other systematic disease non thalassemia\-associated
- •g) Splenectomized patients with platelet count \>900,000 (only for the splenectomized patients who will receive
- •low dose G\-CSF\+ Mozobil)
- •h) 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.
Outcomes
Primary Outcomes
Not specified
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