Clinical trial NCT00737113: Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Official title: Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Allogeneic Stem Cell Transplantation
Keywords: allogeneic stem cell transplantation
Engrafted
subjects
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-08-18
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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.

Primary outcomes:
measure: To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
timeFrame: After 6, 12, 18 patients have enrolled
Secondary outcomes:
measure: To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.
timeFrame: After 6, 12, and 18 patients have enrolled
measure: To evaluate the incidence and severity of infectious complications.
timeFrame: After 6, 12, and 18 patients have enrolled
measure: To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.
timeFrame: After 6, 12, and 18 patients enroll.
measure: To determine the probability and time of neutrophil and platelet recovery on GH therapy.
timeFrame: After 6, 12, and 18 patients enroll
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mitchell Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: