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This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSC835 | Experimental | Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSC835 | Drug | HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC). |
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| Measure | Description | Time Frame |
|---|---|---|
| Absence of Graft Failure at Day 42 | This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neutrophil Recovery Within 42 Days | Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L. | 42 days |
| Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | United States |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Patients were enrolled into the study until approximately nine (9) patients were evaluable for safety as measured by the absence of infusional toxicity and sustained engraftment at Day 100.
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| ID | Title | Description |
|---|---|---|
| FG000 | HSC835 | Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.
| 1 year |
| Incidence of Overall Survival Within One Year | Overall survival is the proportion of patients who were alive at the end of the one year study period. | 1 year |
| Incidence of Relapse-free Survival Within One Year | Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study. | 1 year |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).
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| ID | Title | Description |
|---|---|---|
| BG000 | HSC835 | Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Absence of Graft Failure at Day 42 | This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning. | Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant). | Posted | Number | Participants | 42 days |
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| Secondary | Incidence of Neutrophil Recovery Within 42 Days | Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L. | Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant). | Posted | Number | Participants | 42 days |
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| Secondary | Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year | NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration. | Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant). | Posted | Number | Participants | 1 year |
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| Secondary | Incidence of Overall Survival Within One Year | Overall survival is the proportion of patients who were alive at the end of the one year study period. | Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant). | Posted | Number | Participants | 1 year |
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| Secondary | Incidence of Relapse-free Survival Within One Year | Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study. | Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant). | Posted | Number | Participants | 1 year |
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Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Time Period From Transplant Until 48hrs After Transplant | Adverse events that occurred within the first 48 hours of transplant. | 0 | 9 | 8 | 9 | ||
| EG001 | Time Period From Day 3 up to End of Study | Adverse Events that occurred 48 hours post-transplant. | 9 | 9 | 6 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Acute graft versus host disease | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Cytomegalovirus viraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Human herpesvirus 6 infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Transplant failure | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Chronic lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Plasma cell myeloma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Cytomegalovirus viraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Enterococcal bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Epstein-Barr viraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Human herpesvirus 6 infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Methylobacterium infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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