Loading clinical trials...

Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT00737113•Mitchell Horwitz, MD

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

May 1, 2012

Completion Date

December 1, 2013

Last Updated

March 20, 2014

Enrollment

ACTUAL participants

Conditions

Allogeneic Stem Cell Transplantation

Interventions

Genotropin (Recombinant Human Growth Hormone)

DRUG

A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

NCT06297629

Allogeneic Stem Cell Transplantation

View study

COMPLETEDPHASE1/PHASE2

Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation

NCT02227641

Patients Undergoing Allogeneic Stem Cell Transplantation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions