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This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSC835 | Experimental | HSC835 infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSC835 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT. | The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others. | 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neutrophil Recovery Within 42 Days | Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC > 0.5 x 109/L which occurred for all patients before 42 days post transplant. | 42 days |
| Incidence of Platelet Recovery Within Six Months |
Not provided
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 |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
Not provided
Not provided
Single arm study of HSC835 broken down into 4 subgroups for analyses and 6 subgroups for safety.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SUCBT < 18 Yrs | Single umbilical cord blood transplant(SUCBT) less than 18 yrs |
| FG001 | SUCBT >= 18 Yrs | Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement. |
| 6 months |
| Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only) | Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit | Day 100 |
| Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year | Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year | Day 100 and Month 12 |
| Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year | Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year | Day 100 and Monnth 12 |
| Incidence of Relapse Within One Year | Number of participants with Incidence of relapse within one year | Month 12 |
| Overall Survival (OS) Within One Year | Number of participants with Overall survival (OS) within one year | Month 12 |
| Disease Free Survival (DFS) Within One Year | Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause) | Month 12 |
| FG002 | DUCBT < 18 Yrs | Double umbilical cord blood transplant (DUCBT) less than 18 yrs |
| FG003 | DUCBT >= 18 Yrs | Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SUCBT | Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs |
| BG001 | DUCBT | Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT. | The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others. | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | 32 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Neutrophil Recovery Within 42 Days | Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC > 0.5 x 109/L which occurred for all patients before 42 days post transplant. | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | 42 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Platelet Recovery Within Six Months | Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement. | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only) | Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Day 100 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year | Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Day 100 and Month 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year | Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Day 100 and Monnth 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Relapse Within One Year | Number of participants with Incidence of relapse within one year | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Month 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Within One Year | Number of participants with Overall survival (OS) within one year | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Month 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival (DFS) Within One Year | Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause) | Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs. | Posted | Number | participants | Month 12 |
|
Not provided
Not provided
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 | SUCBT < 18 Yrs | Single umbilical cord blood transplant(SUCBT) less than 18 yrs | 1 | 1 | 1 | 1 | ||
| EG001 | SUCBT >= 18 Yrs | Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs | 7 | 8 | 8 | 8 | ||
| EG002 | DUCBT < 18 Yrs | Double umbilical cord blood transplant (DUCBT) less than 18 yrs | 3 | 3 | 3 | 3 | ||
| EG003 | DUCBT >= 18 Yrs | Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs | 14 | 15 | 15 | 15 | ||
| EG004 | SUCBT | Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs | 8 | 9 | 9 | 9 | ||
| EG005 | DUCBT | Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs | 17 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Acute graft versus host disease in skin | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cerebral aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacillus bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Corynebacterium bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Granulicatella infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Moraxella infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
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 |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D002051 | Burkitt Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| Male |
|
| Absence of graft failure after 32 days |
|
| Units | Counts |
|---|---|
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|---|---|
| Participants |
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| Participants |
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