Graft vs Host DiseasePhase 1NCT00670423
A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
A Phase 1 study testing Tacrolimus, Sirolimus and Bortezomib in people with Graft vs Host Disease and Peripheral Blood Stem Cell Transplantation, run by Jennifer E. Schwartz at 1 site in United States.
Trial summary
The purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs Host Disease, Peripheral Blood Stem Cell Transplantation, Transplantation, Homologous
- What is being tested?
- Tacrolimus, Sirolimus and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2008to 16 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing myeloablative peripheral blood stem cell transplantation
- Have an HLA matched-related or matched-unrelated donor (9/10 antigen or allelic mismatch or 10/10 HLA match permitted).
- Hematological malignancy including patients with: AML, ALL, NHL, Hodgkin's Disease, CLL, CML, MDS and Multiple Myeloma
- Meeting institutional standard criteria for allogeneic PBSC transplantation
Who cannot join
- Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
- History of autologous or allogeneic transplantation
- Evidence of HIV seropositivity
- Evidence of active infection
- Patients with cardiac dysfunction as described in the protocol
- Patients with hypersensitivity to bortezomib, boron or mannitol
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
The purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. This research is being done because there is no treatment that is 100% effective in preventing graft versus host disease.
The goals of this study are to:
- Collect peripheral blood stem cells (PBSCs) from donors for transplant.
- Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.
- Monitor the recipient for risk of infection or side affects associated with the transplant.
- Monitor the recipient for increased immunity following transplantation.
- Conditions
- Graft vs Host Disease, Peripheral Blood Stem Cell Transplantation, Transplantation, Homologous
- Being tested
- Tacrolimus, Sirolimus, Bortezomib
- Keywords
- Tacrolimus, Sirolimus, Bortezomib, Acute Graft Versus Host Disease, Allogeneic Peripheral Blood Stem Cell Transplantation
- 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.
TacrolimusDrug
Also called Prograf®
Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL)
SirolimusDrug
Also called Rapamune®
Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL)
BortezomibDrug
Also called Velcade®
Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used:
Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3
Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3
Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation.
Measured: Baseline through end of study
Secondary outcomes (3)
To assess the toxicity of bortezomib
Measured: Baseline through end of study
To describe engraftment
Measured: Baseline through end of study
To describe the incidence of acute and chronic GVHD
Measured: Baseline through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study start16 May 2008
- Primary completion5 Jul 2012
- Study completion16 Oct 2013
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer E. Schwartz
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Jennifer E. Schwartz, Indiana University
- Investigators
- Jennifer Schwartz, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670423
- Sponsor's protocol ID
- IUCRO-0204
- Other IDs
- 0803-17
- Status last verified
- Aug 2018
- First submitted
- 29 Apr 2008
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
- ClinicalTrials.gov ID
- NCT00670423
- Acronym / sponsor ID
- IUCRO-0204
- Conditions
- Graft vs Host Disease, Peripheral Blood Stem Cell Transplantation, Transplantation, Homologous
- Keywords
- Tacrolimus, Sirolimus, Bortezomib, Acute Graft Versus Host Disease, Allogeneic Peripheral Blood Stem Cell Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jennifer E. SchwartzUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 16 May 2008 (actual)
- Primary completion
- 5 Jul 2012 (actual)
- Study completion
- 16 Oct 2013 (actual)
- First posted
- 1 May 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 purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. This research is being done because there is no treatment that is 100% effective in preventing graft versus host disease.
The goals of this study are to:
- Collect peripheral blood stem cells (PBSCs) from donors for transplant.
- Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.
- Monitor the recipient for risk of infection or side affects associated with the transplant.
- Monitor the recipient for increased immunity following transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing myeloablative peripheral blood stem cell transplantation
- Have an HLA matched-related or matched-unrelated donor (9/10 antigen or allelic mismatch or 10/10 HLA match permitted).
- Hematological malignancy including patients with: AML, ALL, NHL, Hodgkin's Disease, CLL, CML, MDS and Multiple Myeloma
- Meeting institutional standard criteria for allogeneic PBSC transplantation
Key exclusion criteria (6 listed)
- Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
- History of autologous or allogeneic transplantation
- Evidence of HIV seropositivity
- Evidence of active infection
- Patients with cardiac dysfunction as described in the protocol
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 |
|---|---|---|
| TacrolimusAlso: Prograf®Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL) | Drug | – |
| SirolimusAlso: Rapamune®Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL) | Drug | – |
| BortezomibAlso: Velcade®Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used: Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3 Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3 Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3 | Drug | – |
Primary outcome
To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation.
Time frame: Baseline through end of study
3 secondary outcomes
To assess the toxicity of bortezomib
Time frame: Baseline through end of study
To describe engraftment
Time frame: Baseline through end of study
To describe the incidence of acute and chronic GVHD
Time frame: Baseline through end of study
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 16 Aug 2018.
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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.
Jennifer Schwartz, MD principal investigator
Indiana 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 Tacrolimus, Sirolimus and Bortezomib in people with Graft vs Host Disease and Peripheral Blood Stem Cell Transplantation, run by Jennifer E. Schwartz 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 4 inclusion and 6 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 16 Aug 2018. 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 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.
What does the primary outcome measure?
To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation. (time frame: Baseline through end of study). 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 16 Aug 2018.