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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10HL069294-11 | U.S. NIH Grant/Contract | View source | |
| 5U24HL138660 | U.S. NIH Grant/Contract | View source |
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Initiated a new randomized trial per discussion with FDA
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Blood and Marrow Transplant Clinical Trials Network | NETWORK |
| National Cancer Institute (NCI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Guard Treatment | Experimental | Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-Guard | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Complete Response (DoCR) | Evaluate the duration of complete response (DoCR) Early Trial Closure. | Through Day 180 |
| Overall Survival (OS) | Estimate the overall survival (OS) at Day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| Corticosteroid Dose | Corticosteroid-dose (measured in prednisone-equivalent) at baseline, Days 28 and 56 post initiation of T- Guard therapy. | Baseline, Days 28 and 56 |
| Rate of Near-CR | Estimate the rate of near-CR (i.e. CR in GI and Liver with only Stage 1 Skin) at Days 28 and 56 post initiation of T- Guard therapy |
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehdi Hamadani, MD | Medical College of Wisconsin | Principal Investigator |
| John Levine, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Gabrielle Meyers, MD | Oregon Health and Science University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34815518 | Result | 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. |
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Participants from 2 transplant centers willing to participate signed an Institutional Review Board approved Informed Consent Form and had eligibility for enrollment evaluated. If a participant's eligibility was confirmed they were enrolled into the study. The first participant was enrolled in December 2019, and the last participant was enrolled in January 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | T-Guard Treatment | Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2020 |
Not provided
| National Marrow Donor Program |
| OTHER |
A single group of patients will receive T-Guard for treatment of steroid-refractory acute GVHD.
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| 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. | 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. | Days 7, 14, 28, and 56 |
| Non-Relapse Mortality (NRM) | Estimate the cumulative incidence of non-relapse mortality (NRM) at Days 100 and 180. | Days 100 and 180 |
| Relapse-free Survival | Estimate relapse-free survival at Day 180. | Days 180 |
| GVHD-free Survival | Estimate GVHD-free survival at Days 90 and 180 | Days 90 and 180 |
| Cumulative Incidence of Chronic GVHD | Estimate the cumulative incidence of chronic GVHD (cGVHD) at Day 180 | Day 180 |
| Cumulative Incidence of Disease Relapse/Progression | Estimate the cumulative incidence of disease relapse/progression at Day 180 | Day 180 |
| Incidence of Systemic Infections | Describe the incidence of systemic infections | initiation of T-Guard to 28 days post-last dose |
| Incidence of Toxicities | Describe the incidence of CTCAE v5 Grade 3-5 toxicities | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, Days 7, 14, 28, 90, and 180 |
| Days 28 and 56 |
| Discontinuation of Systemic Steroids | Describe discontinuation of systemic steroids by Day 180 post initiation of T-Guard therapy | Day 180 |
| Incidence of CMV Reactivation | Estimate the incidence of CMV reactivation requiring therapy by Day 180 post initiation of T-Guard Therapy | Day 180 |
| Incidence of EBV-associated Lymphoproliferative Disorder or EBV Reactivation | Estimate the incidence of Epstein-Barr Virus (EBV)- associate lymphoproliferative disorder or EBV reactivation requiring therapy with rituximab by Day 180 post initiation of T-Guard therapy | Day 180 |
| Incidence of IMP-related SAEs | Describe the incidence of Investigational Medicinal Product (IMP) related SAEs | Through Day 180 |
| T-cell Subsets and NK Cells | The evolution of specific cell populations over the 180 day follow-up period and, in particular, T-Guard's effect in depleting targeted T cell and NK cell subsets as well as its impact on relevant non-target populations (B cells, monocytes and dendritic cells), will be evaluated. | Baseline and Days 0, 2, 4, 6, 14, 28, 56, 180 |
| Acute GVHD Biomarkers | Serum ST2 and Regenerating Family Member 3 Alpha (REG3α) concentrations and urine 3- Indoxyl Sulfate (3-IS) concentrations will be used to estimate the probability of NRM at Day 180 post-assessment for each patient. The proportion of patients with high risk biomarker status (defined as estimated NRM greater than 0.29) will be described at each time point. | Baseline and Days 7, 14, 28 |
| Patient-reported Outcomes Using a Subset of the PROMIS Measures | Describe changes in patient-reported outcomes (PROs) using a subset of the PROMIS measures from baseline to Days 28, 56, and 180 post initiation of T- Guard therapy | Baseline and Days 28, 56, 180 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Kansas | Westwood | Kansas | 66205 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Initiated T-Guard Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T-Guard Treatment | Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Day 28 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Complete Response (DoCR) | Evaluate the duration of complete response (DoCR) Early Trial Closure. | Study stopped as safety stopping guideline was met. | Posted | Through Day 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Estimate the overall survival (OS) at Day 30. | Posted | Count of Participants | Participants | Day 30 |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (CR or Partial Response (PR)) | Estimate the overall response rate (CR or partial response (PR)) at Days 14, 28, and 56. | Study stopped as safety stopping guideline was met. | Posted | Days 14, 28, and 56 |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Study stopped as safety stopping guideline was met. | Posted | Days 7, 14, 28, and 56 |
|
| |||||||||||||||||||||||||||||
| Secondary | Non-Relapse Mortality (NRM) | Estimate the cumulative incidence of non-relapse mortality (NRM) at Days 100 and 180. | Study stopped as safety stopping guideline was met. | Posted | Days 100 and 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Relapse-free Survival | Estimate relapse-free survival at Day 180. | Study stopped as safety stopping guideline was met. | Posted | Days 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | GVHD-free Survival | Estimate GVHD-free survival at Days 90 and 180 | Study stopped as safety stopping guideline was met. | Posted | Days 90 and 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Chronic GVHD | Estimate the cumulative incidence of chronic GVHD (cGVHD) at Day 180 | Study stopped as safety stopping guideline was met. | Posted | Day 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Disease Relapse/Progression | Estimate the cumulative incidence of disease relapse/progression at Day 180 | Study stopped as safety stopping guideline was met. | Posted | Day 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Systemic Infections | Describe the incidence of systemic infections | Study stopped as safety stopping guideline was met. | Posted | initiation of T-Guard to 28 days post-last dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Toxicities | Describe the incidence of CTCAE v5 Grade 3-5 toxicities | Study stopped as safety stopping guideline was met. | Posted | initiation of T-Guard to 28 days post-last dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of T-Guard - Cinf | Observed and model-predicted concentration of T-Guard at the end of infusion | Study stopped as safety stopping guideline was met. | Posted | 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of T-Guard - CL | Systemic clearance of T-Guard | Study stopped as safety stopping guideline was met. | Posted | 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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 | Study stopped as safety stopping guideline was met. | Posted | 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of T-Guard - t1/2 | Model-predicted terminal half-life of T-Guard | Study stopped as safety stopping guideline was met. | Posted | 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of T-Guard - Vc | Volume of the central compartment | Study stopped as safety stopping guideline was met. | Posted | 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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 | Study stopped as safety stopping guideline was met. | Posted | Baseline, Days 7, 14, 28, 90, and 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Corticosteroid Dose | Corticosteroid-dose (measured in prednisone-equivalent) at baseline, Days 28 and 56 post initiation of T- Guard therapy. | Study stopped as safety stopping guideline was met. | Posted | Baseline, Days 28 and 56 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Near-CR | Estimate the rate of near-CR (i.e. CR in GI and Liver with only Stage 1 Skin) at Days 28 and 56 post initiation of T- Guard therapy | Study stopped as safety stopping guideline was met. | Posted | Days 28 and 56 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Discontinuation of Systemic Steroids | Describe discontinuation of systemic steroids by Day 180 post initiation of T-Guard therapy | Study stopped as safety stopping guideline was met. | Posted | Day 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of CMV Reactivation | Estimate the incidence of CMV reactivation requiring therapy by Day 180 post initiation of T-Guard Therapy | Study stopped as safety stopping guideline was met. | Posted | Day 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of EBV-associated Lymphoproliferative Disorder or EBV Reactivation | Estimate the incidence of Epstein-Barr Virus (EBV)- associate lymphoproliferative disorder or EBV reactivation requiring therapy with rituximab by Day 180 post initiation of T-Guard therapy | Study stopped as safety stopping guideline was met. | Posted | Day 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of IMP-related SAEs | Describe the incidence of Investigational Medicinal Product (IMP) related SAEs | Study stopped as safety stopping guideline was met. | Posted | Through Day 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | T-cell Subsets and NK Cells | The evolution of specific cell populations over the 180 day follow-up period and, in particular, T-Guard's effect in depleting targeted T cell and NK cell subsets as well as its impact on relevant non-target populations (B cells, monocytes and dendritic cells), will be evaluated. | Study stopped as safety stopping guideline was met. | Posted | Baseline and Days 0, 2, 4, 6, 14, 28, 56, 180 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Acute GVHD Biomarkers | Serum ST2 and Regenerating Family Member 3 Alpha (REG3α) concentrations and urine 3- Indoxyl Sulfate (3-IS) concentrations will be used to estimate the probability of NRM at Day 180 post-assessment for each patient. The proportion of patients with high risk biomarker status (defined as estimated NRM greater than 0.29) will be described at each time point. | Study stopped as safety stopping guideline was met. | Posted | Baseline and Days 7, 14, 28 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Patient-reported Outcomes Using a Subset of the PROMIS Measures | Describe changes in patient-reported outcomes (PROs) using a subset of the PROMIS measures from baseline to Days 28, 56, and 180 post initiation of T- Guard therapy | Study stopped as safety stopping guideline was met. | Posted | Baseline and Days 28, 56, 180 |
|
|
The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days.
The adverse event collection followed the clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-Guard Treatment | Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: 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). | 3 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment | Grade 3 |
|
| Cardiac arrest after septic shock | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment | Grade 4 |
|
| Aspergillus pulmonary infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment | Grade 4 |
|
| Sepsis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment | Grade 5 |
|
| Metapneumovirus infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment | Grade 5 |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment | Grade 5 |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment | Grade 3 |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment | Grade 4 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Differential white blood cell count abnormal | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Septic Shock | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
|
Due to the early trial closure and limited study population, only a subset of the protocol-specified planned analyses were performed.
Investigators agree to the disclosure requirements in a Protocol Rider. This states that the BMT CTN DCC will lead on the initial study Publication, and for any subsequent study Publication, with either a) the advance review of Sponsor or b) two years after the completion of the Study at all Study Sites, the DCC, Participating Sites, and Principal Investigators may publicly disclose or submit for Publication an article, poster or other material that includes analysis of the study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric van Hooren, Chief Development Officer | Xenikos | +31 6 109 345 84 | e.vanhooren@xenikos.com |
| May 26, 2021 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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