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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mitchell Horwitz, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00737113
First received: August 15, 2008
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  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:

Drug Information available for: Somatropin
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 ]

Enrollment: 14
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
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
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
Pfizer
Investigators
Principal Investigator: Mitchell Horwitz, MD Duke University
  More Information

No publications provided

Responsible Party: Mitchell Horwitz, 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: December 4, 2012
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 May 19, 2013