Steroid-Refractory Acute Graft Versus Host DiseasePhase 31802NCT04128319
T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)
A Phase 3 study testing T-Guard in people with Steroid-Refractory Acute Graft Versus Host Disease, run by Xenikos at 24 sites in United States.
Trial summary
The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Steroid-Refractory Acute Graft Versus Host Disease
- What is being tested?
- T-Guard
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 24 sitesUnited States
- Study dates
- 21 Nov 2019to 17 Feb 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must be at least 12.0 years of age at the time of consent.
- Patient has undergone first allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of nonmyeloablative, reduced intensity, and myeloablative conditioning regimens are eligible.
- Patients diagnosed with SR-aGVHD after allo-HSCT. SR is defined as aGVHD that:
- Progressed after 3 days of primary treatment with prednisone (or equivalent) of greater than or equal to 2mg/kg/day
- No improvement after 7 days of primary treatment with prednisone (or equivalent) of greater than or equal to 2mg/kg/day.
- Patients with visceral (GI and/or liver) plus skin aGVHD at prednisone (or equivalent) initiation with improvement in skin GVHD without any improvement in visceral GVHD after 7 days of primary treatment with prednisone (or equivalent) of greater than or equal to 2mg/kg/day
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- Previously was treated with prednisone (or equivalent) of greater than or equal to 1mg/kg/day and aGVHD has developed in a previously uninvolved organ system
- Progression and no improvement are defined in the protocol. Improvement or progression in organs is determined by comparing current organ staging to staging at initiation of prednisone (or equivalent) treatment. Staging is performed per MAGIC criteria.
- Evidence of myeloid engraftment (e.g., absolute neutrophil count greater than or equal to 0.5 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- Patients or an impartial witness (in case the patient is capable of providing verbal consent but not capable of signing the informed consent form (ICF)) should have given written informed consent. For patients less than 18 years of age, a written informed consent of the parents or guardian and written assent of the patient will be obtained, per the local requirements.
Who cannot join
- Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD.
- Patients requiring any of the following: mechanical ventilation, vasopressor support, or hemodialysis.
- Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD OR as treatment for SR-aGVHD.
- Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl.
- Patients who have a CK level of greater than 5 times the upper limit of normal.
- Patients with uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
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- Patients with evidence of relapsed, progressing or persistent malignancy.
- Patients with evidence of minimal residual disease requiring withdrawal of systemic immune suppression
- Patients with known hypersensitivity to any of the components murine monoclonal antibodies (mAb) or Recombinant Ricin Toxin A-chain (RTA).
- Patients who have received more than one allo-HSCT.
- Patients with known human immunodeficiency virus infection.
- Female patients who are pregnant, breast feeding, or, if sexually active and of childbearing potential, unwilling to use effective birth control from start of treatment until 30 days after the last infusion of T-Guard.
- Male patients who are, if sexually active and with a female partner of childbearing potential, unwilling to use effective birth control from start of treatment until 65 days after the last infusion of T-Guard.
- Patients with any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data.
- Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21231
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Ohio State University
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55414
Mount Sinai Medical Center
New York, New York, 10029
University of Nebraska
Omaha, Nebraska, 68198
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University in St. Louis
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Children's National Medical Center
Washington D.C., District of Columbia, 20010
University of Kansas
Westwood, Kansas, 66205
About this study
Official title: An Open-Label, Single-Arm, Multicenter Study, of Combination Anti-CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft-versus-Host Disease)
The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).
Read the detailed description
Allogeneic Hematopoietic Cell Transplantation (allo-HSCT) is a potent immunotherapy with curative potential for several hematological disorders. Improvements in survival following allo-HSCT have led to its increasing use, but the leading cause of non-relapse mortality (NRM) remains graft-versus-host-disease (GVHD. Despite recent advances in the understanding of transplantation immune tolerance, aGVHD is a frequent and major complication of allo-HSCT involving activation of donor T-lymphocytes, which ultimately causes host tissue damage. T-Guard has a rapid onset, preferential killing of activated T cells, and short half-life, leading to depletion of allo-reactive T cells and quick post-treatment reconstitution of the immune system.
- Being tested
- T-Guard
- Keywords
- Steroid-refractory acute GVHD, Acute GVHD, GVHD treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-GuardDrug
Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA).
| Study group | Role | What they receive |
|---|---|---|
| T-Guard Treatment | Experimental | Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. Receives: Drug: T-Guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR)
Complete Response at Day 28 is defined as a score of 0 for the GVHD staging in all evaluable organs at the Day 28 visit along with freedom from additional systemic therapy for treatment of acute GVHD.
Measured: Day 28
Secondary outcomes (17)
Duration of Complete Response (DoCR)
Evaluate the duration of complete response (DoCR) Early Trial Closure.
Measured: Through Day 180
Overall Survival (OS)
Estimate the overall survival (OS) at Day 30.
Measured: Day 30
Overall Response Rate (CR or Partial Response (PR))
Estimate the overall response rate (CR or partial response (PR)) at Days 14, 28, and 56.
Measured: Days 14, 28, and 56
Proportions of CR, PR, Mixed Response (MR), no Response (NR) and Progression
Describe proportions of CR, PR, mixed response (MR), no response (NR), and progression of aGVHD at Days 7, 14, 28, and 56.
Measured: Days 7, 14, 28, and 56
Non-Relapse Mortality (NRM)
Estimate the cumulative incidence of non-relapse mortality (NRM) at Days 100 and 180.
Measured: Days 100 and 180
Relapse-free Survival
Estimate relapse-free survival at Day 180.
Measured: Days 180
GVHD-free Survival
Estimate GVHD-free survival at Days 90 and 180
Measured: Days 90 and 180
Cumulative Incidence of Chronic GVHD
Estimate the cumulative incidence of chronic GVHD (cGVHD) at Day 180
Measured: Day 180
Cumulative Incidence of Disease Relapse/Progression
Estimate the cumulative incidence of disease relapse/progression at Day 180
Measured: Day 180
Incidence of Systemic Infections
Describe the incidence of systemic infections
Measured: initiation of T-Guard to 28 days post-last dose
Incidence of Toxicities
Describe the incidence of CTCAE v5 Grade 3-5 toxicities
Measured: initiation of T-Guard to 28 days post-last dose
Pharmacokinetics of T-Guard - Cinf
Observed and model-predicted concentration of T-Guard at the end of infusion
Measured: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - CL
Systemic clearance of T-Guard
Measured: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - AUC
Model-predicted area under the curve from the start of the current infusion until the next infusion or until 48 hours following for the last infusion
Measured: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - t1/2
Model-predicted terminal half-life of T-Guard
Measured: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - Vc
Volume of the central compartment
Measured: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Immunogenicity
Assess the immunogenicity of T-Guard via ADA responses in the form of human anti-SPV-T3a-RTA and anti-WT1-RTA -antibodies evaluated in serum samples
Measured: Baseline, Days 7, 14, 28, 90, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start21 Nov 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Why it stopped: Initiated a new randomized trial per discussion with FDA
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 Steroid-Refractory Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of patients will receive T-Guard for treatment of steroid-refractory acute GVHD.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenikos
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Mehdi Hamadani, MD, Principal investigator, Medical College of WisconsinJohn Levine, MD, Study chair, Icahn School of Medicine at Mount SinaiGabrielle Meyers, MD, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128319
- Sponsor's protocol ID
- BMTCTN1802
- Other IDs
- 2U10HL069294-11, 5U24HL138660
- Acronym
- 1802
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2019
- Last updated
- 16 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meyers G, Hamadani M, Martens M, Ali H, Choe H, Dawson P, Harris AC, van Hooren E, Klaassen W, Leifer E, MacMillan ML, van Oosterhout Y, Perez L, Pusic I, Vo P, Levine JE. Lessons learned from early closure of a clinical trial for steroid-refractory acute GVHD. Bone Marrow Transplant. 2022 Feb;57(2):302-303. doi: 10.1038/s41409-021-01529-x. Epub 2021 Nov 23. No abstract available.
PubMed 34815518
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter Study, of Combination Anti-CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft-versus-Host Disease)
- ClinicalTrials.gov ID
- NCT04128319
- Acronym / sponsor ID
- 1802 / BMTCTN1802
- Keywords
- Steroid-refractory acute GVHD, Acute GVHD, GVHD treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initiated a new randomized trial per discussion with FDA
- Enrolment
- 3 participants (actual)
- Lead sponsor
- XenikosIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 4 Aug 2021
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 an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).
Detailed description
Allogeneic Hematopoietic Cell Transplantation (allo-HSCT) is a potent immunotherapy with curative potential for several hematological disorders. Improvements in survival following allo-HSCT have led to its increasing use, but the leading cause of non-relapse mortality (NRM) remains graft-versus-host-disease (GVHD. Despite recent advances in the understanding of transplantation immune tolerance, aGVHD is a frequent and major complication of allo-HSCT involving activation of donor T-lymphocytes, which ultimately causes host tissue damage. T-Guard has a rapid onset, preferential killing of activated T cells, and short half-life, leading to depletion of allo-reactive T cells and quick post-treatment reconstitution of the immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of patients will receive T-Guard for treatment of steroid-refractory acute GVHD.
| Arm | Type | Receives |
|---|---|---|
| T-Guard Treatment | Experimental | Drug: T-GuardPatients will receive T-Guard for treatment of steroid-refractory acute GVHD. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must be at least 12.0 years of age at the time of consent.
- Patient has undergone first allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of nonmyeloablative, reduced intensity, and myeloablative conditioning regimens are eligible.
- Patients diagnosed with SR-aGVHD after allo-HSCT. SR is defined as aGVHD that:
- Progression and no improvement are defined in the protocol. Improvement or progression in organs is determined by comparing current organ staging to staging at initiation of prednisone (or equivalent) treatment. Staging is performed per MAGIC criteria.
- Evidence of myeloid engraftment (e.g., absolute neutrophil count greater than or equal to 0.5 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
Key exclusion criteria (15 listed)
- Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD.
- Patients requiring any of the following: mechanical ventilation, vasopressor support, or hemodialysis.
- Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD OR as treatment for SR-aGVHD.
- Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl.
- Patients who have a CK level of greater than 5 times the upper limit of normal.
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 |
|---|---|---|
| T-GuardPatients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA). | Drug | T-Guard Treatment |
Primary outcome
Complete Response (CR)
Time frame: Day 28
Complete Response at Day 28 is defined as a score of 0 for the GVHD staging in all evaluable organs at the Day 28 visit along with freedom from additional systemic therapy for treatment of acute GVHD.
17 secondary outcomes
Duration of Complete Response (DoCR)
Time frame: Through Day 180
Overall Survival (OS)
Time frame: Day 30
Overall Response Rate (CR or Partial Response (PR))
Time frame: Days 14, 28, and 56
Proportions of CR, PR, Mixed Response (MR), no Response (NR) and Progression
Time frame: Days 7, 14, 28, and 56
Non-Relapse Mortality (NRM)
Time frame: Days 100 and 180
Relapse-free Survival
Time frame: Days 180
GVHD-free Survival
Time frame: Days 90 and 180
Cumulative Incidence of Chronic GVHD
Time frame: Day 180
Cumulative Incidence of Disease Relapse/Progression
Time frame: Day 180
Incidence of Systemic Infections
Time frame: initiation of T-Guard to 28 days post-last dose
Incidence of Toxicities
Time frame: initiation of T-Guard to 28 days post-last dose
Pharmacokinetics of T-Guard - Cinf
Time frame: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - CL
Time frame: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - AUC
Time frame: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - t1/2
Time frame: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Pharmacokinetics of T-Guard - Vc
Time frame: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)
Immunogenicity
Time frame: Baseline, Days 7, 14, 28, 90, and 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34815518Meyers G, Hamadani M, Martens M, Ali H, Choe H, Dawson P, Harris AC, van Hooren E, Klaassen W, Leifer E, MacMillan ML, van Oosterhout Y, Perez L, Pusic I, Vo P, Levine JE. Lessons learned from early closure of a clinical trial for steroid-refractory acute GVHD. Bone Marrow Transplant. 2022 Feb;57(2):302-303. doi: 10.1038/s41409-021-01529-x. Epub 2021 Nov 23. No abstract available.
- 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.
Mehdi Hamadani, MD principal investigator
Medical College of Wisconsin
John Levine, MD study chair
Icahn School of Medicine at Mount Sinai
Gabrielle Meyers, MD study chair
Oregon Health and Science University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T-Guard in people with Steroid-Refractory Acute Graft Versus Host Disease, run by Xenikos at 24 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 10 inclusion and 15 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 16 Dec 2021. 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. 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 4 Aug 2021). 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?
Complete Response (CR) (time frame: Day 28). 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 NCT04128319, 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 16 Dec 2021.