Graft-vs-Host DiseasePhase 1/2NCT00031148
Keratinocyte Growth Factor to Prevent Acute GVHD
A Phase 1/2 study testing Recombinant Human Keratinocyte Growth Factor (rHuKGF) in people with Graft-vs-Host Disease, run by FDA Office of Orphan Products Development at 1 site in United States.
Trial summary
This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Graft-vs-Host Disease
- What is being tested?
- Recombinant Human Keratinocyte Growth Factor (rHuKGF)
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2003
- Phase
- Phase 1/2
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
- Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
- Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
- Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Who cannot join
- T-cell depletion for GVHD prophylaxis.
- Active hepatitis.
- Pre-existent inflammatory bowel disease requiring active therapy.
- Active uncontrolled infection.
- Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
- Documented hypersensitivity to rHuKGF.
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- Prior enrollment to a study of rHuKGF.
- HIV-positive.
- Pregnant or nursing.
- Active chronic skin disease requiring therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.
Read the detailed description
GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.
Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.
- Conditions
- Graft-vs-Host Disease
- Being tested
- Recombinant Human Keratinocyte Growth Factor (rHuKGF)
- Keywords
- Keratinocyte growth factor, Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, HLA Antigens, Transplantation, Homologous, Recombinant Proteins
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Keratinocyte Growth Factor (rHuKGF)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2002 (estimated)
- Study startSep 2001
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-vs-Host DiseaseStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031148
- Sponsor's protocol ID
- FD-R-2021-01
- Other IDs
- FD-R-002021-01
- Status last verified
- Jan 2002
- First submitted
- 26 Feb 2002
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
- ClinicalTrials.gov ID
- NCT00031148
- Acronym / sponsor ID
- FD-R-2021-01
- Conditions
- Graft-vs-Host Disease
- Keywords
- Keratinocyte growth factor, Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, HLA Antigens, Transplantation, Homologous, Recombinant Proteins
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Study start
- Sep 2001
- Study completion
- Aug 2003
- First posted
- 27 Feb 2002 (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.
This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.
Detailed description
GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.
Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
- Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
- Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
- Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (10 listed)
- T-cell depletion for GVHD prophylaxis.
- Active hepatitis.
- Pre-existent inflammatory bowel disease requiring active therapy.
- Active uncontrolled infection.
- Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
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 |
|---|---|---|
| Recombinant Human Keratinocyte Growth Factor (rHuKGF) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Human Keratinocyte Growth Factor (rHuKGF) in people with Graft-vs-Host Disease, run by FDA Office of Orphan Products Development 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 25 Mar 2015. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 25 Mar 2015.