Not provided
Not provided
Not provided
Not provided
Study terminated due to lack of enrolment..
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amarex Clinical Research | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Stem-Cell Transplantation.
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS undergoing allogeneic HCT.
In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e., 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection. Placebo will be administered -2/-3 days before the stem cell infusion, on the day of stem cell infusion (Day 0) and thereafter on days 7, 14, 21, 28, 42, 56, 70, 84 and 98 as per the study schedule of assessments. Each vial of the Placebo contains 5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5. Each 350 mg dose of placebo consist of 2 SC injections of placebo (5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5) of 2 X 1 mL/inj. on opposite sides of abdomen. |
|
| 350 mg Pro140 | Experimental | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e.,30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection. PRO 140 will be administered -2/-3 days before the stem cell infusion, on the day of stem cell infusion (Day 0) and thereafter on days 7, 14, 21, 28, 42, 56, 70, 84 and 98 as per the study schedule of assessments. Each vial of the PRO 140 product contains 1.4 mL antibody at 175 mg/ml in a buffer containing 5 mM L-histidine, 15.0 mM glycine, 95 mM sodium chloride, 0.3% (w/v) sorbitol, 0.005% (w/v) polysorbate 20 (Tween 20®), and sterile water for injection, at pH of 5.5. Each 350 mg dose of PRO 140 will consist of 2 SC injections of PRO 140 (2 X 1 mL/inj.) on opposite sides of abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 140 | Drug | PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute GVHD by Day 100 | Incidence of Grade II, Grade III or Grade IV acute GVHD by Day-100 | 100 days from first treatment (100 Days post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Severe and Life-threatening (Grade III and Grade IV) Acute GVHD by Day-100 | The number and percentages of subjects with severe and life-threatening (Grade III and Grade IV) acute GVHD by Day-100 will be presented. Chi-square/ Fisher's exact test will be used to compare the incidence between the treatment groups. | 100 Days post-treatment |
Not provided
Inclusion Criteria
Subjects must meet all of the following criteria to be included in the study:
Patients diagnosed with AML or MDS per below:
Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
Patients must have normal organ function as defined below:
Myeloablative allogeneic HCT:
Patients must have a reasonable expectation of ≥ 6 months survival
The donor-recipient HLA match criteria required for participation in this protocol are not research subjects in this study and they must meet criteria as National Marrow Donor Program (NMDP) donors. Procedures for selection of donors and stem cell dose will follow FDA requirements for Blood Products (21 CFR 640) and Human Cellular and Tissue Based Products (21 CFR 1271). The standard institutional practices for stem cell transplants also will be followed. The donors are:
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Patients must understand and voluntarily sign an informed consent form
Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States | ||
| Loyola University Medical Center Cardinal Bernardin Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PRO 140 | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. PRO 140: Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2016 | Feb 9, 2024 |
Not provided
Not provided
Not provided
Not provided
Subjects were randomized to the blinded part of the study using an IRT system. Unblinded pharmacists at clinical sites were notified of the arm to which the subjects were enrolled in order to prepare the appropriate treatment.
| Placebo | Drug | Placebo in parenteral solution. |
|
| Incidence of Organ-specific Acute GVHD by Day-100 | The number and percentages of subjects with organ-specific acute GVHD by Day-100 will be presented by organ category. Chi-square/ Fisher's exact test will be used to compare the incidence between the treatment groups. | 100 Days post-treatment |
| Donor Engraftment Evaluated by T-cell and Myeloid Chimerism in Peripheral Blood | The number and percentages of subjects with donor engraftment failure evaluated by T-cell and myeloid chimerism in peripheral blood will be presented by different treatment groups. Chi-square/ Fisher's exact test will be used to compare the incidence of donor engraftment failure. | 365 days post-initial treatment (T1 Visit) (+/- 14 days) |
| Neutrophil and Platelet Count Recovery | The number and percentages of subjects with neutrophil and platelet count recovery will be presented. Chi-square/ Fisher's exact test will be used to compare the incidence of neutrophil recovery and of platelet recovery between treatment groups. | 100 Days post treatment |
| Changes in ECOG Performance Score | The raw and change from baseline in ECOG performance score will be summarized for each assessment scheduled visit (i.e., Screening visit, Treatment Visits 1, 4, 7, 9, 11, Follow-up Visit 1and Unscheduled Visit(s)). Descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be presented by treatment group. If the Normality assumption is met, t-test will be used to compare the mean of ECOG performance score between the treatment groups and if the Normality assumption is not met, a non-parametric method will be used. | 100 Days post treatment visit 1 |
| GVHD-free Survival (GFS) | GFS will be defined as the elapsed time between the date of transplant until GVHD related death. GVHD-free survival will be compared between the treatment groups using Log-rank test and Kaplan-Meier methods will be used to depict the survival curves. | 100 Days post treatment visit T1 |
| Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions | All data from tolerability assessments of repeated subcutaneous administration of PRO 140 as assessed by study participants and by investigator-evaluation of injection site reactions will be summarized using n, mean, Standard Deviation (SD), minimum and maximum values. | 365 days post-treatment (+/- 14 days) |
| Frequency of Treatment Emergent Adverse Events and Serious Adverse Events | Frequency of treatment emergent adverse events and treatment emergent serious adverse events. | 100 Days post treatment |
| AML or MDS Relapse Rate by Day-100 | AML or MDS relapse rate by Day-100 will be summarized and present by treatment groups. | 100 Days post treatment |
| Changes and Shifts in Laboratory Measurements Over Time | Safety Assessment- The laboratory measurements will include Routine CBC, Biochemistry and Urinalysis.
| 365 days post-treatment (+/- 14 days) |
| Changes in Electrocardiogram (ECG) Parameters Over Time | Safety Assessment-The following ECG parameters will be evaluated: ventricular rate (beats per minute), PR interval (msec), QRS interval (msec), QT interval (msec), and QTc interval (msec). | 365 days post-treatment (+/- 14 days) |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55409 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Transplant Institute Methodist Hospital | San Antonio | Texas | 78229 | United States |
| West Virginia University Medicine | Morgantown | West Virginia | 26506 | United States |
| FG001 | Placebo | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. Placebo: Two 1 mL injections, 175mg/ml each (placebo contains 5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5) to opposite sides of the abdomen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population is defined as the set of subjects who are randomized to PRO 140 or placebo. The ITT population will be the primary analysis population for the analysis of primary and secondary endpoints
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRO 140 | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. PRO 140: Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen. |
| BG001 | Placebo | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. Placebo: Two 1 mL injections, 175mg/ml each (placebo contains 5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5) to opposite sides of the abdomen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| HIV rapid antigen test | 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 | Incidence of Acute GVHD by Day 100 | Incidence of Grade II, Grade III or Grade IV acute GVHD by Day-100 | Study was terminated before outcome data could be obtained. | Posted | 100 days from first treatment (100 Days post treatment) |
|
| ||||||||||||||||||||||
| Secondary | Incidence of Severe and Life-threatening (Grade III and Grade IV) Acute GVHD by Day-100 | The number and percentages of subjects with severe and life-threatening (Grade III and Grade IV) acute GVHD by Day-100 will be presented. Chi-square/ Fisher's exact test will be used to compare the incidence between the treatment groups. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 100 Days post-treatment |
| |||||||||||||||||||||||
| Secondary | Incidence of Organ-specific Acute GVHD by Day-100 | The number and percentages of subjects with organ-specific acute GVHD by Day-100 will be presented by organ category. Chi-square/ Fisher's exact test will be used to compare the incidence between the treatment groups. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 100 Days post-treatment |
| |||||||||||||||||||||||
| Secondary | Donor Engraftment Evaluated by T-cell and Myeloid Chimerism in Peripheral Blood | The number and percentages of subjects with donor engraftment failure evaluated by T-cell and myeloid chimerism in peripheral blood will be presented by different treatment groups. Chi-square/ Fisher's exact test will be used to compare the incidence of donor engraftment failure. | Study was terminated before secondary efficacy endpoint could be obtained. | Posted | 365 days post-initial treatment (T1 Visit) (+/- 14 days) |
| |||||||||||||||||||||||
| Secondary | Neutrophil and Platelet Count Recovery | The number and percentages of subjects with neutrophil and platelet count recovery will be presented. Chi-square/ Fisher's exact test will be used to compare the incidence of neutrophil recovery and of platelet recovery between treatment groups. | Study was terminated before secondary endpoint data could be obtained. | Posted | 100 Days post treatment |
| |||||||||||||||||||||||
| Secondary | Changes in ECOG Performance Score | The raw and change from baseline in ECOG performance score will be summarized for each assessment scheduled visit (i.e., Screening visit, Treatment Visits 1, 4, 7, 9, 11, Follow-up Visit 1and Unscheduled Visit(s)). Descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be presented by treatment group. If the Normality assumption is met, t-test will be used to compare the mean of ECOG performance score between the treatment groups and if the Normality assumption is not met, a non-parametric method will be used. | Trial was terminated before secondary endpoint data could be obtained. | Posted | 100 Days post treatment visit 1 |
| |||||||||||||||||||||||
| Secondary | GVHD-free Survival (GFS) | GFS will be defined as the elapsed time between the date of transplant until GVHD related death. GVHD-free survival will be compared between the treatment groups using Log-rank test and Kaplan-Meier methods will be used to depict the survival curves. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 100 Days post treatment visit T1 |
| |||||||||||||||||||||||
| Secondary | Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions | All data from tolerability assessments of repeated subcutaneous administration of PRO 140 as assessed by study participants and by investigator-evaluation of injection site reactions will be summarized using n, mean, Standard Deviation (SD), minimum and maximum values. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 365 days post-treatment (+/- 14 days) |
| |||||||||||||||||||||||
| Secondary | Frequency of Treatment Emergent Adverse Events and Serious Adverse Events | Frequency of treatment emergent adverse events and treatment emergent serious adverse events. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 100 Days post treatment |
| |||||||||||||||||||||||
| Secondary | AML or MDS Relapse Rate by Day-100 | AML or MDS relapse rate by Day-100 will be summarized and present by treatment groups. | Study was terminated before secondary efficacy endpoint data could be obtained. | Posted | 100 Days post treatment |
| |||||||||||||||||||||||
| Secondary | Changes and Shifts in Laboratory Measurements Over Time | Safety Assessment- The laboratory measurements will include Routine CBC, Biochemistry and Urinalysis.
| Trial was terminated before outcome measure data could be obtained. | Posted | 365 days post-treatment (+/- 14 days) |
| |||||||||||||||||||||||
| Secondary | Changes in Electrocardiogram (ECG) Parameters Over Time | Safety Assessment-The following ECG parameters will be evaluated: ventricular rate (beats per minute), PR interval (msec), QRS interval (msec), QT interval (msec), and QTc interval (msec). | Trial was terminated before secondary outcome measure data was obtained. | Posted | 365 days post-treatment (+/- 14 days) |
|
14 weeks
Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
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 | PRO 140 | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. PRO 140: Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen. | 2 | 6 | 6 | 6 | 6 | 6 |
| EG001 | Placebo | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. Placebo: Two 1 mL injections, 175mg/ml each (placebo contains 5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5) to opposite sides of the abdomen. | 0 | 5 | 1 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute graft versus host disease | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Apoptotic colonopathy | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oral blood blister | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Catheter site bruise | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Infusion site pruritus | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Tissue injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lhermitte's sign | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vulval oedema | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngeal lesion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
This study was stopped prior to completion due to lack of enrolment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Meidling Executive Director Clinical Operations | CytoDyn | (360) 980-8524 | jmeidling@cytodyn.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2016 | Feb 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C420063 | leronlimab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| HIV rapid antigen test positive |
|
|
|
|
|
|
|
|
|
|
| OG001 | Placebo | In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit. Placebo: Two 1 mL injections, 175mg/ml each (placebo contains 5mM Histidine, 15 mM Glycine, 95 mM Sodium Chloride, 0.3% (w/v) Sorbitol, 0.005% (w/v) Polysorbate 20 at a pH of 5.5) to opposite sides of the abdomen. |
|
|