Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

Stopped early · Phase 1

Conditions studied: Allogeneic Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT00737113

Run by

Mitchell Horwitz, MD

People needed

14

Starts

2008-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-03-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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