Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allogeneic Stem Cell Transplantation
Intervention: Genotropin (Recombinant Human Growth Hormone) (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Mitchell Horwitz, MD Official(s) and/or principal investigator(s):
Mitchell Horwitz, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
Secondary outcome: 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. To determine the probability and time of neutrophil and platelet recovery on GH therapy.
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27705, United States
Additional Information
Starting date: September 2008
Last updated: March 18, 2014
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