NEWS HIGHLIGHTS
Published Studies Related to Droxia (Hydroxyurea)
Impact of hydroxyurea on clinical events in the BABY HUG trial. [2012]
The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3
multicenter, randomized, double-blind, placebo-controlled clinical trial of
hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events
between the hydroxyurea and placebo groups...
Effect of hydroxyurea treatment on renal function parameters: results from the
multi-center placebo-controlled BABY HUG clinical trial for infants with sickle
cell anemia. [2012]
CONCLUSION: Treatment with hydroxyurea for 24 months did not influence GFR in
Genotoxicity associated with hydroxyurea exposure in infants with sickle cell
anemia: results from the BABY-HUG Phase III Clinical Trial. [2012]
CONCLUSIONS: These data provide additional support to the safety profile of
Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload. [2011.12.01]
BACKGROUND: Stroke occurs in 5-10% of children with sickle cell anemia (SCA) and has a high (>50%) risk of recurrence without therapy. Chronic monthly erythrocyte transfusions effectively prevent recurrent stroke, but their long-term use is limited by serious side effects, including iron overload. An alternative to transfusion for secondary stroke prevention in SCA is needed, especially one that also improves the management of iron overload... CONCLUSION: Investigation of alternative treatments in SWiTCH could lead to changes in the management of cerebrovascular disease for selected patients with SCA, stroke, and iron overload. Copyright (c) 2011 Wiley-Liss, Inc.
Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: Results from the BABY-HUG phase III clinical trial. [2011.10.19]
CONCLUSIONS: These data provide additional support to the safety profile of hydroxyurea for young patients with SCA, and suggest that genotoxicity in this patient population is low. Pediatr Blood Cancer (c) 2011 Wiley Periodicals, Inc. Copyright (c) 2011 Wiley Periodicals, Inc.
Clinical Trials Related to Droxia (Hydroxyurea)
Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent MG [Recruiting]
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima
when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent
malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary
Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To
evaluate pharmacokinetics of Zactima among MG pts on & not on EIAEDs when combo w imatinib
mesylate & hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on &
not on EIAEDs when combo w Zactima & hydroxyurea Exploratory Objective To evaluate for
evidence of anti-tumor activity of study regimen among RMG pts including radiographic
response rate, 6-month progression free survival rate & median PFS
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera [Recruiting]
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357)
in combination with hydroxyurea in a population of patients with JAK2V617F positive
Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy
for at least 3 months.
Recruited patients will be randomly assigned to one of the following treatment groups:
- group A: 50 mg o. d. of oral GIVINOSTAT (ITF2357) in combination with the maximum
tolerated dose of hydroxyurea monotherapy already in use before admission to the study;
- group B: 50 mg b. i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum
tolerated dose of hydroxyurea monotherapy already in use before admission to the study.
The two groups will be balanced for number and for Centre in order to provide valuable
information on both treatment regimens.
In both groups assigned doses shall remain stable until week 12, which is when the primary
endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.
After the primary endpoint assessment at week 12, one of the following treatment schedules
will be chosen case by case on the basis of the achieved clinical response and continued for
up to 12 further weeks:
- Partial or Complete Response at week 12:
- group A: continue 50 mg o. d.;
- group B: continue 50 mg b. i.d.;
- No Response at week 12:
- group A: increase to 50 mg b. i.d.;
- group B: increase to 50 mg t. i.d.. At any time during study course, if toxicity is
observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then
restarted at a reduced dose level. The drug will be definitively withdrawn in case of
reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last
up to a maximum of 24 cumulative weeks of drug administration.
The study will recruit subjects of both genders with an established diagnosis of JAK2V617F
positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive
therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at
least 3 months.
Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia [Recruiting]
Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to
treat adults with sickle cell anemia. Hydroxyurea has also been tested and used with
children with sickle cell anemia. However, there are not many studies describing the
disposition of drug in children less than 5 years old. The FDA has requested this study to
better understand how children ages 2 to 17 years with sickle anemia absorb and eliminate
the drug (this is called pharmacokinetics). The investigators will measure how much
Hydroxyurea (HU) gets into the bloodstream at different time points after taking this
medication.
Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease [Recruiting]
In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change
of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent
inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon.
Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD,
and this was initially attributed to the stimulation of foetal haemoglobin (HbF). However,
the clinical response does not correlate consistently with the degree and time of HbF
increment, suggesting that HU clinical benefits may involve other mechanisms such as the
induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.
Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea [Recruiting]
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative
therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle
cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who
currently receive chronic transfusions to reduce the risk of primary stroke. For the
alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard
treatment regimen (transfusions), after adjusting for baseline differences, the
hydroxyurea-treated group must have a mean TCD velocity similar to that observed with
transfusion prophylaxis.
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