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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitchell Horwitz, MD
• Collaborator: Pfizer
• Treatments: Hormones

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.