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

This study has been terminated.
(Study was terminated early due to low accrual.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mitchell Horwitz, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00737113
First received: August 15, 2008
Last updated: March 18, 2014
Last verified: March 2014
  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 1

Study Type: Interventional
Study Design: 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:


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 ]

Enrollment: 14
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Mitchell Horwitz, MD
Pfizer
Investigators
Principal Investigator: Mitchell Horwitz, MD Duke University
  More Information

No publications provided

Responsible Party: Mitchell Horwitz, MD, Assoc Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00737113     History of Changes
Other Study ID Numbers: Pro00001910
Study First Received: August 15, 2008
Last Updated: March 18, 2014
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 July 24, 2014