Status:
TERMINATED
Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Lead Sponsor:
Mitchell Horwitz, MD
Collaborating Sponsors:
Pfizer
Conditions:
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00737113
Start Date
September 1 2008
End Date
December 1 2013
Last Update
March 20 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705