Status:
UNKNOWN
Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In Remission
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Chronic Myelogenous Leukemia
Short Stature
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
CML is a myeloproliferative disorder defined by the presence of the Philadelphia chromosome, which arises from the reciprocal translocation of genes on chromosomes 9 and 22.It is rare in childhood and...
Detailed Description
AIMS AND OBJECTIVES: * To study GH-IGF1 axis in children with CML having short stature following Imatinib therapy. * To administer growth hormone therapy to children with CML on Imatinib in remission...
Eligibility Criteria
Inclusion
- CML patients on Imatinib therapy for more than 6 months and in remission will be included in the study if there is
- severe short stature (height SDS \<-3 SD)
- severe growth deceleration (height velocity \<-2 SD over 12 months)
- Height \<-2 SD and height velocity \<-1.0 SD over 12 months
- Height \<-1.5 SD and height velocity \<-1.5 SD over 2 years
Exclusion
- Patients with coexisting systemic illness(e.g. kidney disease, liver disease, celiac disease).
- Patients of CML not receiving Imatinib therapy as prescribed (poor compliance).
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01901666
Start Date
January 1 2013
End Date
December 1 2014
Last Update
July 17 2013
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, India, 160012