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

Allogeneic Stem Cell Transplantation Clinical Trial

Official title:

Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737113
• Other study ID #: Pro00001910
• Status: Terminated
• Phase: Phase 1
• First received: August 15, 2008
• Last updated: March 18, 2014
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Drug:
• Genotropin (Recombinant Human Growth Hormone)
Patients will begin daily subcutaneous (SC) therapy at a starting dose of ~0.02mg/kg body weight. The study drug will continue for 90 days post enrollment.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mitchell Horwitz, MD	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.		After 6, 12, and 18 patients have enrolled	No
Secondary	To evaluate the incidence and severity of infectious complications.		After 6, 12, and 18 patients have enrolled	No
Secondary	To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.		After 6, 12, and 18 patients enroll.	No
Secondary	To determine the probability and time of neutrophil and platelet recovery on GH therapy.		After 6, 12, and 18 patients enroll	No