Graft Versus Host DiseasePhase 2NCT01754389
Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant
A Phase 2 study testing Tacrolimus, Methotrexate and Bortezomib in people with Graft Versus Host Disease, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Tacrolimus, Methotrexate and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced/aggressive hematologic malignancy unlikely to be cured by alternative therapies
- HLA matched unrelated donors or 1-locus HLA mismatched related or unrelated donors
- Adequate organ function
- Willing to use appropriate contraception
Who cannot join
- Pregnant or breastfeeding
- Recipient of prior allogeneic hematopoietic stem cell transplantation
- Recipient of prior abdominal radiation therapy
- HIV positive on combination anti-retroviral therapy
- Seropositive for hepatitis B or C
- Known allergy to bortezomib, boron or mannitol
Show all 14Show fewer
- Myocardial infarction within 6 months prior to enrollment or any other cardiac dysfunction
- Uncontrolled infection
- Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes or gluthathione S-transferases
- Seizures or history of seizures
- Grade greater than or equal to 2 peripheral neuropathy within 21 days of enrollment
- Use of other investigational drugs within 21 days of enrollment
- History of another non-hematologic malignancy except if disease free for at least 5 years or cervical cancer in situ, or basal/squamous cell carcinoma of the skin
- Uncontrolled intercurrent illness
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02215
About this study
Official title: A 3-Arm Randomized Phase II Study of Standard-of-Care vs. Bortezomib Based Graft-Versus-Host Disease Regimen for Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation Patients Lacking HLA-matched Related Donors
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved bortezomib to treat or prevent graft-versus-host disease. Bortezomib is approved by the FDA to treat other human malignancies.
Bortezomib is a drug that has an anti-cancer effect that involves inhibiting cell growth and causing cell death. This drug has been used in other research studies, and information from thos other research studies suggests that bortezomib may help to lower the risk of GVHD after allogeneic stem cell transplantation in patients who have matched unrelated, unmatched related or unrelated donors in this research study.
Read more
Allogeneic stem cell transplantation is a procedure in which selected blood cells taken from your sibling or unrelated donor are given to you. Lower doses of chemotherapy drugs are given before the donor cells are infused in a process known as reduced-intensity conditioning. Stem cell transplant destroys cancer in two ways: The conditioning regimen destroys cancer cells and teh immune cells from the donor can recognize cancer cells and kill them.
A common problem after stem cell transplant is graft-versus-host disease (GVHD). The word "graft" refers to the donor blood cells that you will receive during your transplant. The word "host" refers to the person (in this case, you) receiving the cells. GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. GVHD can cause skin rash, intestinal problems such as nausea, vomiting or diarrhea. GVHD may also damage your liver and cause hepatitis or jaundice. GVHD may also increase your risk of infection.
After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study we are studying the safety and effectiveness of preventing GVHD using bortezomib treatment in combination with other drugs versus standard of care prophylaxis (tacrolimus + methotrexate). If you take part in this study, there is a 33% chance you will receive any one of the following GVHD prevention treatments:
- tacrolimus + methotrexate (standard of care GVHD prophylaxis)
- bortezomib + tacrolimus + methotrexate
- bortezomib + sirolimus + tacrolimus Sirolimus, tacrolimus and methotrexate are drugs that suppress the immune system to try to prevent GVHD.
Read the detailed description
You will undergo some screening tests or procedures to find out if you can be in this research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Possible tests include a medical history, physical exam, laboratory tests, pulmonary function tests, cardiac ejection fraction and a pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.
Because no one knows which of the study options is best, you will be "randomized" into one of the study groups (described below). Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance of being placed in any of the groups.
Before your transplant you will receiving conditioning therapy. The conditioning therapy for this study involves fludarabine and busulfex. These drugs will be given five, four, three and two days before your transplant (Days -5 through -2). Both these chemotherapy drugs are commonly used in allogeneic stem cell transplantation. On Day 0, you will receive selected blood cells taken from your sibling or unrelated donor.
You will receive 1 of 3 GVHD prophylaxis plans depending on which one you are randomized to:
- Arm A will receive tacrolimus + methotrexate
- Arm B will receive bortezomib + tacrolimus + methotrexate
- Arm C will receive bortezomib + sirolimus + tacrolimus
Tacrolimus (Arm A, B and C) will be started three days before your transplant (Day -3). You will be given tacrolimus initially intravenously (through a needle in a vein in your arm or through a "central line", a catheter or tube placed in the large vein under your collarbone or your neck) and later by mouth. You will continue to take tacrolimus for 3 to 6 months after your transplant. Your physician will discuss your tacrolimus dose with you.
Methotrexate (Arms A and B) will be given intravenously one, three, six and eleven days after your transplant (Days 1,3,6 and 11).
Bortezomib (Arms B and C) will be given intravenously one, four and seven days after your transplant (Days 1,4 and 7).
Sirolimus (Arm C only) will start three days before your transplant (Day -3). You will be given sirolimus initially intravenously and then later by mouth. You will need to continue to take your sirolimus for 3 to 6 months after your transplant. Your physician will discuss your sirolimus dose with you.
To help with engraftment, you will be given the drug G-CSF (Neupogen) starting the day after your transplant, until your white blood cells recover. You will receive other medications as part of standard of care to help prevent you from getting infections. You will also receive medications to help prevent seizures during your conditioning therapy.
Each week for the first four weeks and 2,3,6 and 12 months following your transplant, you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. If you are taking bortezomib, you will have an exam and may be asked to fill out an additional questionnaire about potential symptoms of numbness, tingling, weakness or pain on days 1,4 and 7 after your transplant.
Each week for the first four weeks and 12 months following your transplant, you will have blood drawn (approximately 6 teaspoons) to monitor your progress and health following transplant. If you receive methotrexate and/or bortezomib, you will have an additional blood draw on those days.
Approximately 12 months following your transplant, a needle will be inserted into your hip bone and a small amount of bone marrow cells and a sample of bone are removed.
- Conditions
- Graft Versus Host Disease
- Being tested
- Tacrolimus, Methotrexate, Bortezomib, Sirolimus
- 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
MethotrexateDrug
BortezomibDrug
SirolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Standard of Care) | Active comparator | Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant Receives: Drug: Tacrolimus; Drug: Methotrexate |
| Arm B (Experimental) | Experimental | Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant Receives: Drug: Tacrolimus; Drug: Methotrexate; Drug: Bortezomib |
| Arm C (Experimental) | Experimental | Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Receives: Drug: Tacrolimus; Drug: Bortezomib; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Incidence of Grade II-IV GVHD
The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.
Measured: 6 months
Secondary outcomes (4)
Percentage of Participants With Non-relapse Mortality
Non-relapse mortality by 1 year after stem cell infusion.
Measured: 1 year
Percentage of Participants With Relapse
Relapse relapse-cum-immunosuppression-free survival at 1 year after stem cell infusion
Measured: 1 year
Percentage of Participants With Progression-free and Overall Survival
Progression-free and overall survival 1 year post stem cell infusion
Measured: 1 year
Percentage of Participants With Chronic Graft Versus Host Disease
Rates of chronic GVHD 1 year after stem cell infusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Koreth, MD, Dana-Farber Cancer Institute
- Investigators
- John Koreth, DPhil, MBBS, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754389
- Sponsor's protocol ID
- 12-404
- Status last verified
- Jun 2017
- First submitted
- 13 Dec 2012
- Last updated
- 18 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Koreth J, Kim HT, Lange PB, Poryanda SJ, Reynolds CG, Rai SC, Armand P, Cutler CS, Ho VT, Glotzbecker B, Yusuf R, Nikiforow S, Chen YB, Dey B, McMasters M, Ritz J, Blazar BR, Soiffer RJ, Antin JH, Alyea EP 3rd. Bortezomib-based immunosuppression after reduced-intensity conditioning hematopoietic stem cell transplantation: randomized phase II results. Haematologica. 2018 Mar;103(3):522-530. doi: 10.3324/haematol.2017.176859. Epub 2018 Jan 11.
PubMed 29326124
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Arm Randomized Phase II Study of Standard-of-Care vs. Bortezomib Based Graft-Versus-Host Disease Regimen for Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation Patients Lacking HLA-matched Related Donors
- ClinicalTrials.gov ID
- NCT01754389
- Acronym / sponsor ID
- 12-404
- Conditions
- Graft Versus Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 18 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved bortezomib to treat or prevent graft-versus-host disease. Bortezomib is approved by the FDA to treat other human malignancies.
Bortezomib is a drug that has an anti-cancer effect that involves inhibiting cell growth and causing cell death. This drug has been used in other research studies, and information from thos other research studies suggests that bortezomib may help to lower the risk of GVHD after allogeneic stem cell transplantation in patients who have matched unrelated, unmatched related or unrelated donors in this research study.
Allogeneic stem cell transplantation is a procedure in which selected blood cells taken from your sibling or unrelated donor are given to you. Lower doses of chemotherapy drugs are given before the donor cells are infused in a process known as reduced-intensity conditioning. Stem cell transplant destroys cancer in two ways: The conditioning regimen destroys cancer cells and teh immune cells from the donor can recognize cancer cells and kill them.
A common problem after stem cell transplant is graft-versus-host disease (GVHD). The word "graft" refers to the donor blood cells that you will receive during your transplant. The word "host" refers to the person (in this case, you) receiving the cells. GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. GVHD can cause skin rash, intestinal problems such as nausea, vomiting or diarrhea. GVHD may also damage your liver and cause hepatitis or jaundice. GVHD may also increase your risk of infection.
After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study we are studying the safety and effectiveness of preventing GVHD using bortezomib treatment in combination with other drugs versus standard of care prophylaxis (tacrolimus + methotrexate). If you take part in this study, there is a 33% chance you will receive any one of the following GVHD prevention treatments:
- tacrolimus + methotrexate (standard of care GVHD prophylaxis)
- bortezomib + tacrolimus + methotrexate
- bortezomib + sirolimus + tacrolimus Sirolimus, tacrolimus and methotrexate are drugs that suppress the immune system to try to prevent GVHD.
Detailed description
You will undergo some screening tests or procedures to find out if you can be in this research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Possible tests include a medical history, physical exam, laboratory tests, pulmonary function tests, cardiac ejection fraction and a pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.
Because no one knows which of the study options is best, you will be "randomized" into one of the study groups (described below). Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance of being placed in any of the groups.
Before your transplant you will receiving conditioning therapy. The conditioning therapy for this study involves fludarabine and busulfex. These drugs will be given five, four, three and two days before your transplant (Days -5 through -2). Both these chemotherapy drugs are commonly used in allogeneic stem cell transplantation. On Day 0, you will receive selected blood cells taken from your sibling or unrelated donor.
You will receive 1 of 3 GVHD prophylaxis plans depending on which one you are randomized to:
- Arm A will receive tacrolimus + methotrexate
- Arm B will receive bortezomib + tacrolimus + methotrexate
- Arm C will receive bortezomib + sirolimus + tacrolimus
Tacrolimus (Arm A, B and C) will be started three days before your transplant (Day -3). You will be given tacrolimus initially intravenously (through a needle in a vein in your arm or through a "central line", a catheter or tube placed in the large vein under your collarbone or your neck) and later by mouth. You will continue to take tacrolimus for 3 to 6 months after your transplant. Your physician will discuss your tacrolimus dose with you.
Methotrexate (Arms A and B) will be given intravenously one, three, six and eleven days after your transplant (Days 1,3,6 and 11).
Bortezomib (Arms B and C) will be given intravenously one, four and seven days after your transplant (Days 1,4 and 7).
Sirolimus (Arm C only) will start three days before your transplant (Day -3). You will be given sirolimus initially intravenously and then later by mouth. You will need to continue to take your sirolimus for 3 to 6 months after your transplant. Your physician will discuss your sirolimus dose with you.
To help with engraftment, you will be given the drug G-CSF (Neupogen) starting the day after your transplant, until your white blood cells recover. You will receive other medications as part of standard of care to help prevent you from getting infections. You will also receive medications to help prevent seizures during your conditioning therapy.
Each week for the first four weeks and 2,3,6 and 12 months following your transplant, you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. If you are taking bortezomib, you will have an exam and may be asked to fill out an additional questionnaire about potential symptoms of numbness, tingling, weakness or pain on days 1,4 and 7 after your transplant.
Each week for the first four weeks and 12 months following your transplant, you will have blood drawn (approximately 6 teaspoons) to monitor your progress and health following transplant. If you receive methotrexate and/or bortezomib, you will have an additional blood draw on those days.
Approximately 12 months following your transplant, a needle will be inserted into your hip bone and a small amount of bone marrow cells and a sample of bone are removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Standard of Care) | Active comparator | Drug: Tacrolimus, Drug: MethotrexateTacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant |
| Arm B (Experimental) | Experimental | Drug: Tacrolimus, Drug: Methotrexate, Drug: BortezomibBortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant |
| Arm C (Experimental) | Experimental | Drug: Tacrolimus, Drug: Bortezomib, Drug: SirolimusBortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed advanced/aggressive hematologic malignancy unlikely to be cured by alternative therapies
- HLA matched unrelated donors or 1-locus HLA mismatched related or unrelated donors
- Adequate organ function
- Willing to use appropriate contraception
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding
- Recipient of prior allogeneic hematopoietic stem cell transplantation
- Recipient of prior abdominal radiation therapy
- HIV positive on combination anti-retroviral therapy
- Seropositive for hepatitis B or C
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 |
|---|---|---|
| Tacrolimus | Drug | Arm A (Standard of Care), Arm B (Experimental), Arm C (Experimental) |
| Methotrexate | Drug | Arm A (Standard of Care), Arm B (Experimental) |
| Bortezomib | Drug | Arm B (Experimental), Arm C (Experimental) |
| Sirolimus | Drug | Arm C (Experimental) |
Primary outcome
Percentage of Participants With Incidence of Grade II-IV GVHD
Time frame: 6 months
The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.
4 secondary outcomes
Percentage of Participants With Non-relapse Mortality
Time frame: 1 year
Percentage of Participants With Relapse
Time frame: 1 year
Percentage of Participants With Progression-free and Overall Survival
Time frame: 1 year
Percentage of Participants With Chronic Graft Versus Host Disease
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29326124Koreth J, Kim HT, Lange PB, Poryanda SJ, Reynolds CG, Rai SC, Armand P, Cutler CS, Ho VT, Glotzbecker B, Yusuf R, Nikiforow S, Chen YB, Dey B, McMasters M, Ritz J, Blazar BR, Soiffer RJ, Antin JH, Alyea EP 3rd. Bortezomib-based immunosuppression after reduced-intensity conditioning hematopoietic stem cell transplantation: randomized phase II results. Haematologica. 2018 Mar;103(3):522-530. doi: 10.3324/haematol.2017.176859. Epub 2018 Jan 11.
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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.
John Koreth, DPhil, MBBS principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus, Methotrexate and Bortezomib in people with Graft Versus Host Disease, run by Dana-Farber Cancer Institute at 4 sites 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 14 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Yes. Results are posted in the registry (first posted 18 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Incidence of Grade II-IV GVHD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754389, which also lists 1 linked publication.
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 18 Jul 2017.