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Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation

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Conditions:		Allogeneic Stem Cell Transplantation
Purpose:		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.
Study Summary:		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.
Criteria:		Inclusion Criteria: - Age ≥12 - <90 days following Allogeneic Transplantation. - ANC>500/ul for 3 consecutive days. - ≥50% donor cells in all cellular fractions tested. - No active grade II or higher acute graft versus host disease - Receiving ≤ 1 mg/kg/day Methylprednisolone or equivalent - Documentation of morphologic or radiographic remission within 45 days of protocol enrollment Exclusion Criteria: - Patients with acute organ dysfunction requiring monitoring in the Intensive Care unit or receiving invasive interventions that may include, Hemodialysis ,CVVHD, or any form of mechanical ventilation including CPAP/BiPap at the time of starting therapy. - Pregnant or lactating patients and those without a negative pregnancy test. - Patients must have a life expectancy of at least 3 months. - Patients must be HIV negative. - Patients must not be receiving investigational agents for treatment of GVHD. - Patients with severe veno-occlusive disease as determined by standard criteria. - Patients with Type 1 Diabetes at the time of initiation of stem cell transplantation.
NCT ID:		NCT00737113
Primary Contact:		Principal Investigator Mitchell Horwitz, MD Duke University
Backup Contact:		N/A
Location Contact:		Durham, North Carolina 27705 United States There is no listed contact information for this specific location. Site Status: N/A

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