The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.
The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic stem cell transplant. The secondary objectives of this study are: to evaluate the incidence of mortality due to opportunistic infections in the first 6 months, to evaluate the incidence and severity of infectious complications, to assess laboratory parameters of post-transplant immune recovery in patients on GH therapy and to determine the probability and time of neutrophil and platelet recovery on GH therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
14
Patients will begin daily subcutaneous (SC) therapy at a starting dose of \~0.02mg/kg body weight. The study drug will continue for 90 days post enrollment.
Duke University Medical Center
Durham, North Carolina, United States
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
Time frame: After 6, 12, 18 patients have enrolled
To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.
Time frame: After 6, 12, and 18 patients have enrolled
To evaluate the incidence and severity of infectious complications.
Time frame: After 6, 12, and 18 patients have enrolled
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.
Time frame: After 6, 12, and 18 patients enroll.
To determine the probability and time of neutrophil and platelet recovery on GH therapy.
Time frame: After 6, 12, and 18 patients enroll
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