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

Sponsor:	Duke University
Collaborator:	Pfizer
Information provided by (Responsible Party):	Duke University
ClinicalTrials.gov Identifier:	NCT00737113

Purpose

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.

Condition	Intervention	Phase
Allogeneic Stem Cell Transplantation	Drug: Genotropin (Recombinant Human Growth Hormone)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation [ Time Frame: After 6, 12, 18 patients have enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the incidence of mortality due to opportunistic infections in the first 6 months. [ Time Frame: After 6, 12, and 18 patients have enrolled ] [ Designated as safety issue: No ]
To evaluate the incidence and severity of infectious complications. [ Time Frame: After 6, 12, and 18 patients have enrolled ] [ Designated as safety issue: No ]
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll. ] [ Designated as safety issue: No ]
To determine the probability and time of neutrophil and platelet recovery on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Other Names:

rh-GH
Genotropin

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737113

Contacts

Contact: Mitchell Horwitz, MD

919-668-1045

mitchell.horwitz@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: Mitchell Horwitz, MD 919-668-1045 mitchell.horwitz@duke.edu
Principal Investigator: Mitchell Horwitz, MD

Sponsors and Collaborators

Duke University

Pfizer

Investigators

Principal Investigator:

Mitchell Horwitz, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00737113 History of Changes
Other Study ID Numbers:	Pro00001910
Study First Received:	August 15, 2008
Last Updated:	November 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

allogeneic stem cell transplantation
Engrafted
subjects

Additional relevant MeSH terms:

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012