Leukemia, Myelocytic, AcutePhase 3NCT00406393
Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
A Phase 3 study testing Tacrolimus, Methotrexate and Sirolimus in people with Leukemia, Myelocytic, Acute and Leukemia, Lymphocytic, Acute, run by Medical College of Wisconsin at 24 sites in 2 countries.
Trial summary
The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in… Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Chronic
- What is being tested?
- Tacrolimus, Methotrexate and Sirolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Nov 2006to Oct 2015
- Phase
- Phase 3
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6/6 HLA-matched sibling, defined by Class I (HLA-A and B) serologic typing (or higher resolution) and Class II (HLA-DRBI) molecular typing, who is willing to donate peripheral blood stem cells, and meets institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells, according to individual transplant center criteria. Pediatric patients for whom a pediatric sibling donor is not anticipated to be a suitable leukapheresis candidate are not eligible.
- Karnofsky performance status of at least 70% or Lansky performance status of at least 70% for participants less than 16 years old
- For participants less than 18 years old, willing and able to take oral medications, per the treating physician's recommendations
Who cannot join
- Prior allogeneic or autologous transplant using any hematopoietic stem cell source
- Seropositive for the human immunodeficiency virus (HIV)
- Uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)
- Pregnant (positive serum human chorionic gonadotropin [β-HCG] test) or breastfeeding within 4 weeks of study entry
- Kidney function: serum creatinine outside the normal range for age, or measured creatinine clearance less than 50 mL/min/1.72m^2 within 4 weeks of study entry
- Liver function: most recent direct bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than two times the upper limit of normal within 4 weeks of study entry
Show all 13Show fewer
- Lung disease: in adults, forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) less than 60% of predicted value (corrected for hemoglobin); in children, overt hypoxemia, as measured by an oxygen saturation of less than 92% within 4 weeks of study entry
- Cardiac ejection fraction of less than 45% in adults and children, or less than 26% shortening fraction in children within 4 weeks of study entry
- Cholesterol level greater than 500 mg/dL or triglyceride level greater than 500 mg/dL while being treated, or not on appropriate lipid-lowering therapy within 4 weeks of study entry
- Prior history of allergy to sirolimus
- Requires voriconazole at time of study entry
- Currently receiving another investigational drug unless cleared by the protocol officer or protocol chair
- Participants with a history of cancer, other than resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent for more than 5 years previously will be allowed. Cancer treated with curative intent for less than 5 years previously will not be allowed unless approved by the protocol officer or protocol chair.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0914
Emory University
Atlanta, Georgia, 30322
DFCI/Brigham & Women's Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106-5061
Ohio State, Arthur G. James Cancer Hospital
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27705
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
UCSD Medical Center
La Jolla, California, 92093
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-5156
University of Minnesota
Minneapolis, Minnesota, 55455
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University/MCV Hospital
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Texas Transplant Institute
San Antonio, Texas, 78229
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
Official title: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)
The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
Read the detailed description
BACKGROUND:
Stem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders. A common problem that may occur after a stem cell transplant is a condition known as GVHD. The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD. The combinations of medications in this study are:
- Sirolimus and tacrolimus
- Methotrexate and tacrolimus
Doctors want to know if one combination is better than the other or if they both have the same result.
DESIGN NARRATIVE:
Participants will receive one of the two conditioning regimens described in the protocol, at the discretion of the transplant physician. The transplant physician must choose among these regimens prior to the participant's assignment to the GVHD prophylaxis treatment. Conditioning regimens will vary by center, but will be the same for all participants at each center. Stem cell donors will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration. Standard post-transplant care will be administered. Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest.
Participants will be followed for 114 days post-randomization for evaluation of the primary endpoint, with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints.
- Conditions
- Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes
- Being tested
- Tacrolimus, Methotrexate, Sirolimus
- Keywords
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf®, FK506
Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible.
The target serum level for tacrolimus is 5-10 ng/mL.
MethotrexateDrug
Also called MTX
Methotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation.
SirolimusDrug
Also called Rapamycin, Rapamune
Adults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose.
Children: Children aged < 12.0 years OR weighing < 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram.
The target serum level for sirolimus is 3-12 ng/mL.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus/Methotrexate | Active comparator | Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis. Receives: Drug: Tacrolimus; Drug: Methotrexate |
| Tacrolimus/Sirolimus | Experimental | Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis. Receives: Drug: Tacrolimus; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Grades II-IV Acute GVHD-free Survival
The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.
Measured: Day 114
Secondary outcomes (11)
Incidence of Acute GVHD
Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.
Measured: Measured at Day 100
Time to Neutrophil and Platelet Engraftment
Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) > 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count > 20,000/mcL for three consecutive measurements over three or more days.
Measured: Measured through Day 100
Mucositis Severity
Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.
Measured: Measured at Day 21
Rate of Veno-occlusive Disease (VOD)
VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.
Measured: Measured through Day 100
Thrombotic Microangiopathy (TMA) Infection
The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.
Measured: Measured through Day 100
Reactivation of Cytomegalovirus (CMV) Infection
Measured: Measured at Year 2
Treatment-related Mortality
Measured: Measured at Day 100 and Year 2
Malignant Disease Relapse
Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.
Measured: Measured at Year 2
Overall Survival
Measured: Measured at Year 2
Infections
Measured: Measured at Year 2
Time to Discharge After Transplant
Measured: Measured at Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2012
- Study completionOct 2015
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 Leukemia, Myelocytic, AcuteStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Horowitz, MD, Study director, Center for International Blood and Marrow Transplant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406393
- Sponsor's protocol ID
- BMTCTN0402
- Other IDs
- U01HL069294, BMT CTN 0402, U01HL069294-05
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2006
- Last updated
- 4 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Findings will be published in a manuscript.
Publications
Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.
PubMed 24982504
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)
- ClinicalTrials.gov ID
- NCT00406393
- Acronym / sponsor ID
- BMTCTN0402
- Conditions
- Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes
- Keywords
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
Detailed description
BACKGROUND:
Stem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders. A common problem that may occur after a stem cell transplant is a condition known as GVHD. The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD. The combinations of medications in this study are:
- Sirolimus and tacrolimus
- Methotrexate and tacrolimus
Doctors want to know if one combination is better than the other or if they both have the same result.
DESIGN NARRATIVE:
Participants will receive one of the two conditioning regimens described in the protocol, at the discretion of the transplant physician. The transplant physician must choose among these regimens prior to the participant's assignment to the GVHD prophylaxis treatment. Conditioning regimens will vary by center, but will be the same for all participants at each center. Stem cell donors will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration. Standard post-transplant care will be administered. Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest.
Participants will be followed for 114 days post-randomization for evaluation of the primary endpoint, with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus/Methotrexate | Active comparator | Drug: Tacrolimus, Drug: MethotrexatePatients will be given Tacrolimus and Methotrexate for GVHD prophylaxis. |
| Tacrolimus/Sirolimus | Experimental | Drug: Tacrolimus, Drug: SirolimusPatients will be given Tacrolimus and Sirolimus for GVHD prophylaxis. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6/6 HLA-matched sibling, defined by Class I (HLA-A and B) serologic typing (or higher resolution) and Class II (HLA-DRBI) molecular typing, who is willing to donate peripheral blood stem cells, and meets institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells, according to individual transplant center criteria. Pediatric patients for whom a pediatric sibling donor is not anticipated to be a suitable leukapheresis candidate are not eligible.
- Karnofsky performance status of at least 70% or Lansky performance status of at least 70% for participants less than 16 years old
- For participants less than 18 years old, willing and able to take oral medications, per the treating physician's recommendations
Key exclusion criteria (13 listed)
- Prior allogeneic or autologous transplant using any hematopoietic stem cell source
- Seropositive for the human immunodeficiency virus (HIV)
- Uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)
- Pregnant (positive serum human chorionic gonadotropin [β-HCG] test) or breastfeeding within 4 weeks of study entry
- Kidney function: serum creatinine outside the normal range for age, or measured creatinine clearance less than 50 mL/min/1.72m^2 within 4 weeks of study entry
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®, FK506Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible. The target serum level for tacrolimus is 5-10 ng/mL. | Drug | Tacrolimus/Methotrexate, Tacrolimus/Sirolimus |
| MethotrexateAlso: MTXMethotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation. | Drug | Tacrolimus/Methotrexate |
| SirolimusAlso: Rapamycin, RapamuneAdults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose. Children: Children aged < 12.0 years OR weighing < 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram. The target serum level for sirolimus is 3-12 ng/mL. | Drug | Tacrolimus/Sirolimus |
Primary outcome
Rate of Grades II-IV Acute GVHD-free Survival
Time frame: Day 114
The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.
11 secondary outcomes
Incidence of Acute GVHD
Time frame: Measured at Day 100
Time to Neutrophil and Platelet Engraftment
Time frame: Measured through Day 100
Mucositis Severity
Time frame: Measured at Day 21
Rate of Veno-occlusive Disease (VOD)
Time frame: Measured through Day 100
Thrombotic Microangiopathy (TMA) Infection
Time frame: Measured through Day 100
Reactivation of Cytomegalovirus (CMV) Infection
Time frame: Measured at Year 2
Treatment-related Mortality
Time frame: Measured at Day 100 and Year 2
Malignant Disease Relapse
Time frame: Measured at Year 2
Overall Survival
Time frame: Measured at Year 2
Infections
Time frame: Measured at Year 2
Time to Discharge After Transplant
Time frame: Measured at Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24982504Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.
- Individual participant dataSharing planned: Yes. Findings will be published in a manuscript.
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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.
Mary Horowitz, MD study director
Center for International Blood and Marrow Transplant Research
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus, Methotrexate and Sirolimus in people with Leukemia, Myelocytic, Acute and Leukemia, Lymphocytic, Acute, run by Medical College of Wisconsin at 24 sites in 2 countries.
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 3 inclusion and 13 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Mar 2016). 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?
Rate of Grades II-IV Acute GVHD-free Survival (time frame: Day 114). 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 NCT00406393, 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 4 Jan 2023.