Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
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ClinicalTrials.gov Identifier: NCT00737113
Recruitment Status :
(Study was terminated early due to low accrual.)
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.
Condition or disease
Allogeneic Stem Cell Transplantation
Drug: Genotropin (Recombinant Human Growth Hormone)
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.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
<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
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.