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

March 18, 2014 updated by: Mitchell Horwitz, MD

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
Time Frame: After 6, 12, 18 patients have enrolled
After 6, 12, 18 patients have enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.
Time Frame: After 6, 12, and 18 patients have enrolled
After 6, 12, and 18 patients have enrolled
To evaluate the incidence and severity of infectious complications.
Time Frame: After 6, 12, and 18 patients have enrolled
After 6, 12, and 18 patients have enrolled
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.
Time Frame: After 6, 12, and 18 patients enroll.
After 6, 12, and 18 patients enroll.
To determine the probability and time of neutrophil and platelet recovery on GH therapy.
Time Frame: After 6, 12, and 18 patients enroll
After 6, 12, and 18 patients enroll

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitchell Horwitz, MD

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (ESTIMATE)

August 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001910

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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