Graft vs. Host DiseasePhase 2NCT02867384
Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation
A Phase 2 study testing Obinutuzumab in people with Graft vs. Host Disease, run by Dana-Farber Cancer Institute at 5 sites in United States.
Trial summary
This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs. Host Disease
- What is being tested?
- Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Nov 2016to 14 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects deemed potentially eligible by their treating physicians will be screened for enrollment after d+60 from transplantation
- Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation are eligible.
- Peripheral blood stem cells must have been used as the stem cell source.
- Patients must have received transplantation from donors (both related and unrelated) who are identical at 8 HLA loci (A, B, C and DR1), or mismatched at no more than 1 locus (7/8). Among related donors, HLA C typing is not required (6/6 HLA matches). Class I typing is to be performed by PCR-SSP techniques and CDC techniques. Class II typing is performed by PCR-RFLP +/- PCR-SSP techniques.
- No evidence of relapsed or residual malignancy within 30 days of trial entry. All patients must undergo appropriate staging for their malignancy (i.e. bone marrow aspiration for the Leukemias and PET-CT scanning for the lymphomas). Evidence of a persistent Cytogenetic abnormality will constitute evidence of residual or relapsed disease in the Leukemias, where present. Individuals with CLL are eligible if there is no more than 20% residual leukemia in the bone marrow at the time of study entry.
- Patients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment. Chimerism within 30 days of study entry must be greater than, equal to, or no more than 5% less than the chimerism measured at approximately day+30 (if performed).
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- Age ≥ 18.0
- ECOG performance status ≤2 (Karnofsky ≥60%) (See Appendix A)
- Participants must have normal marrow function as defined by:
- WBC ≥ 2,500/μL
- Absolute Neutrophil Count ≥ 1,000/μL
- Platelets ≥ 50,000/μL
- Ability to understand and the willingness to sign a written informed consent document.
- The effects of Obinutuzumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Obinutuzumab administration.
Who cannot join
- Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow.
- Allogeneic stem cell transplantation using in vivo or ex vivo T cell depletion, either by cell manipulation or with T cell depleting antibodies (Any anti-thymocyte globulin preparation or alemtuzumab given within 30 days of transplantation)
- Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD. Prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used > 30 days prior to enrollment.
- Any evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD. Ongoing, tapering therapy for resolved acute GVHD is permissible.
- Any evidence of prior active or resolved chronic GVHD.
- History of severe allergic reaction to Obinutuzumab
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- No Donor Lymphocyte Infusion (DLI) prior to day 100, and no plans for a DLI in the upcoming 30 days.
- Evidence of any active uncontrolled infection (bacterial, viral or fungal) or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV. Evidence of Hepatitis B exposure includes the presence of Hepatitis B surface antigenemia, a positive serological test for Hepatitis B core antibody or nucleic acid testing (NAT testing) that is positive for Hepatitis B. Vaccination to Hepatitis B is not an exclusion criteria.
- Pregnancy or lactation. Negative pregnancy test is required within the screening window
- Active use of any other investigational agents.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Stanford University
Palo Alto, California, 94305
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Randomized Phase 2 Study of Obinutuzumab for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation
This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease.
The FDA (the U.S. Food and Drug Administration) has not approved Obinutuzumab for prevention of chronic Graft-vs.-Host Disease (cGVHD), but it has been approved for other uses.
In this research study, the investigators are aiming to determine the effect of Obinutuzumab on the incidence of corticosteroid-requiring cGVHD after allogeneic Hematopoetic Cell Transplant (aHCT).
Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted from one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to 'reject' the body. This process is referred to as Graft-vs. -Host Disease and may occur at any time, although generally not earlier than one hundred days after transplantation.
The immune system produces two types of lymphocytes (white blood cells), B cells and T cells. B cells are part of the 'memory' for the immune system, and they make antibodies (proteins) when bacteria, viruses or other potentially harmful materials enter the body. Obinutuzumab is an antibody, a molecule that targets certain cells by binding to specific parts of the target cell. In this case, Obinutuzumab will bind to a component of B cells called CD20, resulting in the B cell getting killed. It is thought that reducing the number of B cells will reduce the chances of developing cGVHD after transplant. Previous studies with another antibody targeting CD20 on B cells suggests that there may be a reduced chance of developing cGVHD and the need to prescribe Corticosteroids to treat cGVHD when B cells are killed.
This is a randomized, placebo controlled trial. This means that approximately half of the study participants will receive Obinutuzumab, and the other half will receive a placebo (saline solution). A computer will decide which participants will receive Obinutuzumab or placebo, and neither the participant or the study doctor will know which the participant has received until the study is completed. It is important to note that the current standard is to receive no therapy specifically to prevent cGVHD.
- Conditions
- Graft vs. Host Disease
- Being tested
- Obinutuzumab, Placebo
- Keywords
- Graft vs. Host Disease
- 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.
ObinutuzumabDrug
Also called Gazyva
B cell depletion
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab | Active comparator | Obinutuzumab or will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation.
* Premedication with histamine blockers and acetaminophen will be provided
* All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Receives: Drug: Obinutuzumab |
| Placebo | Sham comparator | Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation.
* Premedication with histamine blockers and acetaminophen will be provided
* All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticosteroid-Requiring Chronic Graft-Versus-Host Disease (cGVHD) Rate
Corticosteroid-requiring cGVHD is defined as the percentage of participants who develop chronic Graft Versus Host Disease cGVHD requiring treatment with corticosteroids within the first year following Hematopoietic Cell Transplantation HCT.
Measured: 1 year
Secondary outcomes (10)
All Chronic Graft-Versus-Host Disease (cGVHD) Rate
All cGVHD rate is defined as the percentage of participants who develop chronic Graft Versus Host Disease cGVHD following Hematopoietic Cell Transplantation HCT.
Measured: at 1 year and 2 years
Immunosuppression-Free Survival at 1 Year (IFS1)
IFS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first. Participants who are alive without relapse and who have not initiated systemic immunosuppression will be censored at the date of last disease or survival assessment.
Measured: 1 year
Immunosuppression-Free Survival at 2 Years (IFS2)
IFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first. Participants who are alive without relapse and who have not initiated systemic immunosuppression will be censored at the date of last disease or survival assessment.
Measured: 2 years
NIH Moderate-Severe Chronic Graft-Versus-Host Disease (cGVHD) Rate
NIH moderate-severe cGVHD rate is defined as the percentage of participants who developed NIH moderate-severe cGVHD following Hematopoietic Cell Transplantation HCT.
Measured: at 1 year and at 2 years
Cumulative Incidence Of Non-Relapse Mortality (NRM)
Cumulative incidence of NRM is defined as the probability of death from any cause other than disease relapse or progression following treatment or transplantation. Deaths due to relapse or disease progression are treated as competing events. Participants who are alive without relapse or death are censored at the date of last follow-up.
Measured: at 1 year and at 2 years
Cumulative Incidence of Relapse
Cumulative Incidence of Relapse is defined as the percentage probability of disease relapse following treatment, with death without prior relapse treated as a competing risk. Patients who are alive and relapse-free at last follow-up will be censored.
Measured: at 1 year and 2 years
Progression-Free Survival at 1 Year (PFS1)
PFS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Patients who are alive without disease progression at the time of last disease assessment will be censored at that date.
Measured: 1 year
Progression-Free Survival at 2 Years (PFS2)
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Patients who are alive without disease progression at the time of last disease assessment will be censored at that date.
Measured: 2 years
Overall Survival at 1 Year (OS1)
OS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of last follow-up will be censored at the date of last contact.
Measured: 1 year
Overall Survival at 2 Years (OS2)
OS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of last follow-up will be censored at the date of last contact.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start29 Nov 2016
- Primary completion29 Nov 2023
- Study completion14 Nov 2024
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 vs. 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech
- Responsible party
- Principal investigator, Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Corey Cutler, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867384
- Sponsor's protocol ID
- 16-256
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2016
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cutler C, Kim HT, El Banna H, Halloran E, Matozel E, Ho VT, Koreth J, Gooptu M, Shapiro R, Kelkar A, Gibson C, Nikiforow S, Nageshwar P, Reynolds C, Ansuinelli M, Tamada R, Au C, Panaro K, Gervais C, DeFilipp Z, El-Jawahri A, Chen YB, El Jurdi N, Weisdorf D, Couriel D, Lee C, Arai S, Sahaf B, Bacigalupi J, Ji K, Soiffer R, Miklos D, Antin JH, Ritz J. Randomized, Placebo-Controlled Trial of B-Cell Depletion for Prevention of Corticosteroid-Requiring Chronic Graft-Versus-Host Disease. J Clin Oncol. 2026 Jun;44(16):1529-1539. doi: 10.1200/JCO-25-03104. Epub 2026 Apr 30.
PubMed 42060875
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Obinutuzumab for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02867384
- Acronym / sponsor ID
- 16-256
- Conditions
- Graft vs. Host Disease
- Keywords
- Graft vs. Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Roche-Genentech
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 12 Mar 2025
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 studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease.
The FDA (the U.S. Food and Drug Administration) has not approved Obinutuzumab for prevention of chronic Graft-vs.-Host Disease (cGVHD), but it has been approved for other uses.
In this research study, the investigators are aiming to determine the effect of Obinutuzumab on the incidence of corticosteroid-requiring cGVHD after allogeneic Hematopoetic Cell Transplant (aHCT).
Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted from one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to 'reject' the body. This process is referred to as Graft-vs. -Host Disease and may occur at any time, although generally not earlier than one hundred days after transplantation.
The immune system produces two types of lymphocytes (white blood cells), B cells and T cells. B cells are part of the 'memory' for the immune system, and they make antibodies (proteins) when bacteria, viruses or other potentially harmful materials enter the body. Obinutuzumab is an antibody, a molecule that targets certain cells by binding to specific parts of the target cell. In this case, Obinutuzumab will bind to a component of B cells called CD20, resulting in the B cell getting killed. It is thought that reducing the number of B cells will reduce the chances of developing cGVHD after transplant. Previous studies with another antibody targeting CD20 on B cells suggests that there may be a reduced chance of developing cGVHD and the need to prescribe Corticosteroids to treat cGVHD when B cells are killed.
This is a randomized, placebo controlled trial. This means that approximately half of the study participants will receive Obinutuzumab, and the other half will receive a placebo (saline solution). A computer will decide which participants will receive Obinutuzumab or placebo, and neither the participant or the study doctor will know which the participant has received until the study is completed. It is important to note that the current standard is to receive no therapy specifically to prevent cGVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab | Active comparator | Drug: ObinutuzumabObinutuzumab or will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials |
| Placebo | Sham comparator | Drug: PlaceboPlacebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects deemed potentially eligible by their treating physicians will be screened for enrollment after d+60 from transplantation
- Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation are eligible.
- Peripheral blood stem cells must have been used as the stem cell source.
- Patients must have received transplantation from donors (both related and unrelated) who are identical at 8 HLA loci (A, B, C and DR1), or mismatched at no more than 1 locus (7/8). Among related donors, HLA C typing is not required (6/6 HLA matches). Class I typing is to be performed by PCR-SSP techniques and CDC techniques. Class II typing is performed by PCR-RFLP +/- PCR-SSP techniques.
- No evidence of relapsed or residual malignancy within 30 days of trial entry. All patients must undergo appropriate staging for their malignancy (i.e. bone marrow aspiration for the Leukemias and PET-CT scanning for the lymphomas). Evidence of a persistent Cytogenetic abnormality will constitute evidence of residual or relapsed disease in the Leukemias, where present. Individuals with CLL are eligible if there is no more than 20% residual leukemia in the bone marrow at the time of study entry.
Key exclusion criteria (10 listed)
- Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow.
- Allogeneic stem cell transplantation using in vivo or ex vivo T cell depletion, either by cell manipulation or with T cell depleting antibodies (Any anti-thymocyte globulin preparation or alemtuzumab given within 30 days of transplantation)
- Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD. Prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used > 30 days prior to enrollment.
- Any evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD. Ongoing, tapering therapy for resolved acute GVHD is permissible.
- Any evidence of prior active or resolved chronic 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 |
|---|---|---|
| ObinutuzumabAlso: GazyvaB cell depletion | Drug | Obinutuzumab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Corticosteroid-Requiring Chronic Graft-Versus-Host Disease (cGVHD) Rate
Time frame: 1 year
Corticosteroid-requiring cGVHD is defined as the percentage of participants who develop chronic Graft Versus Host Disease cGVHD requiring treatment with corticosteroids within the first year following Hematopoietic Cell Transplantation HCT.
10 secondary outcomes
All Chronic Graft-Versus-Host Disease (cGVHD) Rate
Time frame: at 1 year and 2 years
Immunosuppression-Free Survival at 1 Year (IFS1)
Time frame: 1 year
Immunosuppression-Free Survival at 2 Years (IFS2)
Time frame: 2 years
NIH Moderate-Severe Chronic Graft-Versus-Host Disease (cGVHD) Rate
Time frame: at 1 year and at 2 years
Cumulative Incidence Of Non-Relapse Mortality (NRM)
Time frame: at 1 year and at 2 years
Cumulative Incidence of Relapse
Time frame: at 1 year and 2 years
Progression-Free Survival at 1 Year (PFS1)
Time frame: 1 year
Progression-Free Survival at 2 Years (PFS2)
Time frame: 2 years
Overall Survival at 1 Year (OS1)
Time frame: 1 year
Overall Survival at 2 Years (OS2)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42060875Cutler C, Kim HT, El Banna H, Halloran E, Matozel E, Ho VT, Koreth J, Gooptu M, Shapiro R, Kelkar A, Gibson C, Nikiforow S, Nageshwar P, Reynolds C, Ansuinelli M, Tamada R, Au C, Panaro K, Gervais C, DeFilipp Z, El-Jawahri A, Chen YB, El Jurdi N, Weisdorf D, Couriel D, Lee C, Arai S, Sahaf B, Bacigalupi J, Ji K, Soiffer R, Miklos D, Antin JH, Ritz J. Randomized, Placebo-Controlled Trial of B-Cell Depletion for Prevention of Corticosteroid-Requiring Chronic Graft-Versus-Host Disease. J Clin Oncol. 2026 Jun;44(16):1529-1539. doi: 10.1200/JCO-25-03104. Epub 2026 Apr 30.
- Individual participant dataSharing planned: No
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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.
Corey Cutler, MD MPH principal investigator
Dana-Farber Cancer Institute
5 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 Obinutuzumab in people with Graft vs. Host Disease, run by Dana-Farber Cancer Institute at 5 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 14 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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 12 Mar 2025). 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?
Corticosteroid-Requiring Chronic Graft-Versus-Host Disease (cGVHD) Rate (time frame: 1 year). 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 NCT02867384, 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 19 Feb 2026.