Recombinant Human Growth Hormone (RH-GH)For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unrelated Umbilical Cord Blood Transplantation
Intervention: Genotropin (Recombinant Human Growth Hormone) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Paul Szabolcs, MD, Principal Investigator, Affiliation: Duke University
Mitchell Horwitz, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Mitchell Horwitz, MD, Phone: 919-668-1045, Email: mitchell.horwitz@duke.edu
Summary
The primary objective of this study is to define the safety of recombinant human growth
hormone (rh-GH, Genotropin) in a patients undergoing unrelated cord blood transplantation.
Clinical Details
Official title: A Phase I Trial To Determine the Safety of Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Unrelated Cord Blood Transplantation
Study design: Other, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Primary outcome: To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing unrelated cord blood 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 of recombinant human growth
hormone (rh-GH, Genotropin) in a population of patients undergoing unrelated cord blood
transplantation. 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: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥12 and ≤ 50 years.
- <90 days following Unrelated Cord Blood 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
Exclusion Criteria:
- Patients with malignancies who are not in remission at the time of transplant
- Patients with malignancies that have progressed after transplant
- 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 concurrently involved in any clinical trial that affects GVHD.
- Patients with severe veno-occlusive disease as determined by standard criteria.
Locations and Contacts
Mitchell Horwitz, MD, Phone: 919-668-1045, Email: mitchell.horwitz@duke.edu
Duke University Medical Center, Durham, North Carolina 27705, United States; Recruiting
Paul Szabolcs, MD, Principal Investigator
Mitchell Horwitz, MD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: September 2012
Last updated: October 19, 2009
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