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

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ClinicalTrials.gov Identifier: NCT00737113
Recruitment Status : Terminated (Study was terminated early due to low accrual.)
First Posted : August 18, 2008
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Drug: Genotropin (Recombinant Human Growth Hormone) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
Study Start Date : September 2008
Primary Completion Date : May 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the incidence and severity of infectious complications. [ Time Frame: After 6, 12, and 18 patients have enrolled ]
  3. To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll. ]
  4. To determine the probability and time of neutrophil and platelet recovery on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll ]

Eligibility Criteria

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Mitchell Horwitz, MD, Duke University Medical Center:
allogeneic stem cell transplantation
Engrafted
subjects

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs