Allogeneic Stem Cell TransplantationPhase 1NCT00737113
Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
A Phase 1 study testing Genotropin (Recombinant Human Growth Hormone) in people with Allogeneic Stem Cell Transplantation, run by Mitchell Horwitz, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- Genotropin (Recombinant Human Growth Hormone)
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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
- Being tested
- Genotropin (Recombinant Human Growth Hormone)
- Keywords
- allogeneic stem cell transplantation, Engrafted, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotropin (Recombinant Human Growth Hormone)Drug
Also called rh-GH, Genotropin
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 being measured
The primary outcome is the main question the study is designed to answer.
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
Measured: After 6, 12, 18 patients have enrolled
Secondary outcomes (4)
To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.
Measured: After 6, 12, and 18 patients have enrolled
To evaluate the incidence and severity of infectious complications.
Measured: After 6, 12, and 18 patients have enrolled
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.
Measured: After 6, 12, and 18 patients enroll.
To determine the probability and time of neutrophil and platelet recovery on GH therapy.
Measured: After 6, 12, and 18 patients enroll
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionDec 2013
Why it stopped: Study was terminated early due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitchell Horwitz, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Mitchell Horwitz, MD, Duke University
- Investigators
- Mitchell Horwitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737113
- Sponsor's protocol ID
- Pro00001910
- Status last verified
- Mar 2014
- First submitted
- 15 Aug 2008
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00737113
- Acronym / sponsor ID
- Pro00001910
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- allogeneic stem cell transplantation, Engrafted, subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to low accrual.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mitchell Horwitz, MDUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotropin (Recombinant Human Growth Hormone)Also: rh-GH, GenotropinPatients 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. | Drug | – |
Primary outcome
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
4 secondary outcomes
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
To evaluate the incidence and severity of infectious complications.
Time frame: 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.
To determine the probability and time of neutrophil and platelet recovery on GH therapy.
Time frame: After 6, 12, and 18 patients enroll
Results and safety
The study was stopped early (reason given: Study was terminated early due to low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Horwitz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genotropin (Recombinant Human Growth Hormone) in people with Allogeneic Stem Cell Transplantation, run by Mitchell Horwitz, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated early due to low accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.