Allogeneic Stem Cell Transplantation
Conditions
Keywords
allogeneic stem cell transplantation, Engrafted, subjects
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.
Interventions
DRUGGenotropin (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.
Sponsors
Pfizer
Mitchell Horwitz, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation | After 6, 12, 18 patients have enrolled |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of mortality due to opportunistic infections in the first 6 months. | After 6, 12, and 18 patients have enrolled |
| To evaluate the incidence and severity of infectious complications. | After 6, 12, and 18 patients have enrolled |
| To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. | After 6, 12, and 18 patients enroll. |
| To determine the probability and time of neutrophil and platelet recovery on GH therapy. | After 6, 12, and 18 patients enroll |
Countries
United States
Outcome results
None listed