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

NCT ID: NCT00737113

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Allogeneic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

rh-GH; Genotropin

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Mitchell Horwitz, MD

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Horwitz, MD

Assoc Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mitchell Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00001910

Identifier Type: -

Identifier Source: org_study_id