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

Mitchell Horwitz, MD

Status and phase: Terminated; Phase 1

Conditions: Allogeneic Stem Cell Transplantation

Treatments: Drug: Genotropin (Recombinant Human Growth Hormone)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00737113

Pro00001910

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 14 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.