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

Phase 1

Terminated

• Conditions: Allogeneic Stem Cell Transplantation

• Registration Number: NCT00737113
• Lead Sponsor: Mitchell Horwitz, MD

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. 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.

Study Timeline

• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Study Start: 2008-09
• Primary Completion: 2012-05
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation	After 6, 12, 18 patients have enrolled

Secondary Outcome Measures

Name	Time	Method
To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.	After 6, 12, and 18 patients have enrolled
To evaluate the incidence and severity of infectious complications.	After 6, 12, and 18 patients have enrolled
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.	After 6, 12, and 18 patients enroll.
To determine the probability and time of neutrophil and platelet recovery on GH therapy.	After 6, 12, and 18 patients enroll

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States