Acute Graft-Versus-Host DiseasePhase 2GIGVHDNCT02245412
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
A Phase 2 study testing ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly and ALXN1007 20 mg/kg twice weekly in people with Acute Graft-Versus-Host Disease and GIGVHD, run by Alexion Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft-Versus-Host Disease, GIGVHD
- What is being tested?
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly and ALXN1007 20 mg/kg twice weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 14 Nov 2014to 27 Feb 2017
- 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
- Participants must be males or females age 18 years or older.
- Participants with Stage 1 to 4 (per the Modified Keystone Grading Schema) acute GVHD of the lower GI tract, without signs of chronic GVHD, at the time of diagnosis, which developed in the first 180 days following allogeneic hematopoietic cell transplantation (HCT) using bone marrow, peripheral blood, or cord blood; or after preplanned donor lymphocyte infusion.
- Participants are willing to undergo or must have had an endoscopy of the upper and/or lower GI tract and biopsy to confirm GI GVHD.
- Participants must be receiving systemic corticosteroids.
- Participants with an absolute neutrophil count (ANC) >500/microliter (μL) at Screening.
- Participants and spouse/partner who are of childbearing potential must be using high effective contraception consisting of 2 forms of birth control (at least 1 of which much be barrier method) starting at Screening and continuing through the entire study (for at least 3 months after the last dose of ALXN1007 if study treatment is stopped early or participant withdraws consent).
- Male participants must not donate sperm during the Screening and Treatment periods, and for at least 3 months after the last dose of ALXN1007.
- Stage of acute GVHD of the lower GI tract will be determined using the Modified Keystone Grading Schema.
Who cannot join
- Participants with a body weight > 140 kg (for Cohorts dosing 20 mg/kg of ALXN1007 and higher only).
- Participants with signs and symptoms of chronic GVHD.
- Participants with an active uncontrolled infection.
- Participants who test positive for Clostridium difficile (C. difficile) at Screening.
- Participants with relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
- Participants who received an unplanned (not part of the original transplant therapy plan) donor lymphocyte infusion.
Show all 13Show fewer
- Participants who received previous systemic treatment for acute GVHD, except for a maximum of 3 days (72 hours) of 2 mg/kg corticosteroid therapy.
- Participants with unresolved veno-occlusive disease of the liver.
- Participants with creatinine clearance <40 milliliters (mL)/minute at Screening, as calculated by the Cockcroft-Gault formula.
- Participants known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Participants known to have an uncontrolled thyroid disorder.
- Participants who are pregnant, breast feeding, or sexually active and unwilling to use effective birth control for the duration of the study.
- Participants who participated in any other investigational drug trial or had exposure to any other investigational agent, device, or procedure <4 weeks prior to Screening and throughout the entire trial, with the exception of investigational drugs administered prophylactically for cytomegalovirus (CMV) post allogeneic HCT.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Emory University Hospital
Atlanta, Georgia, 30322
Roswell Park Cancer Institute
Buffalo, New York, 14263
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota Medicine - Hematology, Oncology and Transplantation Office
Minneapolis, Minnesota, 55455
Abramson Cancer Perelman Center for Advanced Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University in St. Louis
St Louis, Missouri, 63110
France3 sites
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François
Gironde, 33604
CHU de Grenoble - Hôpital Nord
Grenoble, Isere, 38043
Hôpital Saint-Louis
Paris, 75010
About this study
Official title: A Phase 2A Study of ALXN1007 in Subjects With Newly Diagnosed Acute Graft-Versus-Host Disease Involving the Lower Gastrointestinal Tract
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.
Read the detailed description
This was a Phase 2A open-label, non-randomized study to evaluate the safety, tolerability, PK/PD, and efficacy of ALXN1007 (a C5a inhibitor) in up to 36 participants with newly diagnosed acute GVHD of the lower GI tract. All participants meeting the inclusion and exclusion criteria for the study were to receive ALXN1007 over an 8 week treatment period. Participants in Cohort 1, the first dosing cohort, were to receive 10 milligrams/kilogram (mg/kg) ALXN1007 administered IV once weekly for 8 weeks. Participants in Cohort 2 were to receive 20 mg/kg ALXN1007 IV once weekly for 8 weeks. Participants in Cohort 3 were to receive 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. All doses of ALXN1007 were to be administered as a continuous IV infusion.
- Conditions
- Acute Graft-Versus-Host Disease, GIGVHD
- Being tested
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Keywords
- GIGVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1007 10 mg/kg once weeklyBiological
ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
ALXN1007 20 mg/kg once weeklyBiological
ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
ALXN1007 20 mg/kg twice weeklyBiological
ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
| Study group | Role | What they receive |
|---|---|---|
| ALXN1007 10 mg/kg once weekly | Experimental | Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks. Receives: Biological: ALXN1007 10 mg/kg once weekly |
| ALXN1007 20 mg/kg once weekly | Experimental | Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants. Receives: Biological: ALXN1007 20 mg/kg once weekly |
| ALXN1007 20 mg/kg twice weekly | Experimental | Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants. Receives: Biological: ALXN1007 20 mg/kg twice weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28
The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash <25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = >50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = <500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = >1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = >15 mg/dL.
Measured: Day 28
Secondary outcomes (3)
Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007
The Tmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).
Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.
Measured: Predose up to 72 hours postdose
PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007
The Cmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).
Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.
Measured: Predose up to 72 hours postdose
PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007
The AUC of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).
Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.
Measured: Predose up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start14 Nov 2014
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Why it stopped: Terminated early at the Sponsor's discretion, not due to safety concerns.
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.
- Other trials for Acute Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245412
- Sponsor's protocol ID
- ALXN1007-GIGVHD-201
- Acronym
- GIGVHD
- Status last verified
- Dec 2018
- First submitted
- 17 Sep 2014
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Study of ALXN1007 in Subjects With Newly Diagnosed Acute Graft-Versus-Host Disease Involving the Lower Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT02245412
- Acronym / sponsor ID
- GIGVHD / ALXN1007-GIGVHD-201
- Conditions
- Acute Graft-Versus-Host Disease, GIGVHD
- Keywords
- GIGVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early at the Sponsor's discretion, not due to safety concerns.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2014 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.
Detailed description
This was a Phase 2A open-label, non-randomized study to evaluate the safety, tolerability, PK/PD, and efficacy of ALXN1007 (a C5a inhibitor) in up to 36 participants with newly diagnosed acute GVHD of the lower GI tract. All participants meeting the inclusion and exclusion criteria for the study were to receive ALXN1007 over an 8 week treatment period. Participants in Cohort 1, the first dosing cohort, were to receive 10 milligrams/kilogram (mg/kg) ALXN1007 administered IV once weekly for 8 weeks. Participants in Cohort 2 were to receive 20 mg/kg ALXN1007 IV once weekly for 8 weeks. Participants in Cohort 3 were to receive 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. All doses of ALXN1007 were to be administered as a continuous IV infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALXN1007 10 mg/kg once weekly | Experimental | Biological: ALXN1007 10 mg/kg once weeklyCohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks. |
| ALXN1007 20 mg/kg once weekly | Experimental | Biological: ALXN1007 20 mg/kg once weeklyCohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants. |
| ALXN1007 20 mg/kg twice weekly | Experimental | Biological: ALXN1007 20 mg/kg twice weeklyCohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be males or females age 18 years or older.
- Participants with Stage 1 to 4 (per the Modified Keystone Grading Schema) acute GVHD of the lower GI tract, without signs of chronic GVHD, at the time of diagnosis, which developed in the first 180 days following allogeneic hematopoietic cell transplantation (HCT) using bone marrow, peripheral blood, or cord blood; or after preplanned donor lymphocyte infusion.
- Participants are willing to undergo or must have had an endoscopy of the upper and/or lower GI tract and biopsy to confirm GI GVHD.
- Participants must be receiving systemic corticosteroids.
- Participants with an absolute neutrophil count (ANC) >500/microliter (μL) at Screening.
Key exclusion criteria (13 listed)
- Participants with a body weight > 140 kg (for Cohorts dosing 20 mg/kg of ALXN1007 and higher only).
- Participants with signs and symptoms of chronic GVHD.
- Participants with an active uncontrolled infection.
- Participants who test positive for Clostridium difficile (C. difficile) at Screening.
- Participants with relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
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 |
|---|---|---|
| ALXN1007 10 mg/kg once weeklyALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg. | Biological | ALXN1007 10 mg/kg once weekly |
| ALXN1007 20 mg/kg once weeklyALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg. | Biological | ALXN1007 20 mg/kg once weekly |
| ALXN1007 20 mg/kg twice weeklyALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg. | Biological | ALXN1007 20 mg/kg twice weekly |
Primary outcome
Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28
Time frame: Day 28
The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash <25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = >50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = <500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = >1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = >15 mg/dL.
3 secondary outcomes
Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007
Time frame: Predose up to 72 hours postdose
PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007
Time frame: Predose up to 72 hours postdose
PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007
Time frame: Predose up to 72 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Graft-Versus-Host Disease
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease
Not yet recruitingPhase 1/2
Jaktinib for Steroid-Refractory Acute Graft-Versus-Host Disease
Acute Graft vs Host Disease
Active, not recruitingPhase 2
Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation
Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 2/3
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL
Acute Lymphoblastic Leukemia (ALL), Stem Cell Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly and ALXN1007 20 mg/kg twice weekly in people with Acute Graft-Versus-Host Disease and GIGVHD, run by Alexion Pharmaceuticals, Inc. at 12 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 8 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: stopped early, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 6 Oct 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?
Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 (time frame: Day 28). 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 3 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.