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

Sponsor

Mitchell Horwitz, MD (Other)

Overall Status

Terminated

CT.gov ID

NCT00737113

Collaborator

Pfizer (Industry)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Stem Cell Transplantation	Drug: Genotropin (Recombinant Human Growth Hormone)	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

Mitchell Horwitz, MD
Pfizer

Investigators

Principal Investigator: Mitchell Horwitz, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitchell Horwitz, MD, Assoc Professor of Medicine, Duke University

ClinicalTrials.gov Identifier:

NCT00737113

Other Study ID Numbers:

Pro00001910

First Posted:

Aug 18, 2008

Last Update Posted:

Mar 20, 2014

Last Verified:

Mar 1, 2014

Keywords provided by Mitchell Horwitz, MD, Assoc Professor of Medicine, Duke University

allogeneic stem cell transplantation

Engrafted

subjects

Additional relevant MeSH terms:

Hormones

Study Results

No Results Posted as of Mar 20, 2014