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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation

Conditions
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Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Genotropin (Recombinant Human Growth Hormone)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic stem cell transplantation, Engrafted, subjects