Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)
Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib 200 | Experimental | 200mg fostamatinib bid n=60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Phase II Trial to evaluate the efficacy of 200mg fostamatinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis. | Week 8 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernadette Weidman, RN, MSN, PMP | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | United States | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| D4302C00001\_CSR\_Synopsis | View source |
Not provided
Not provided
This study was conducted in the US and UK. Patient enrolment was completed on 14 June 2013. However three patients, considered by the Investigator to still be receiving clinical benefit, continue to receive fostamatinib. A total of 102 patients were enrolled and 68 received Fostamatinib doses of 100mg or 200mg and 38 Screen Failures.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 100mg BID | 100mg Fostmatinib BID |
| FG001 | 200mg BID | 200mg Fostmatinib BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Denver |
| Colorado |
| United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Rochester | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Hackensack | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | London | United Kingdom |
| Research Site | Southampton | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Most patients were male (69.1%). The mean age (± standard deviation) was 63.6 ± 12.6 years.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 100mg BID | 100mg Fostmatinib BID |
| BG001 | 200mg BID | 200mg Fostmatinib BID |
| 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 | Objective Response Rate | Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis. | Full analysis set - all randomised patients | Posted | Number | 95% Confidence Interval | Patients | Week 8 |
|
|
|
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 | 100mg BID | 100mg Fostmatinib BID | 3 | 21 | 21 | 21 | ||
| EG001 | 200mg BID | 200mg Fostmatinib BID | 12 | 47 | 44 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations |
| |||
| CELLULITIS | Infections and infestations |
| |||
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations |
| |||
| NEUTROPENIC SEPSIS | Infections and infestations |
| |||
| CARDIAC ARREST | Cardiac disorders |
| |||
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders |
| |||
| SINUS TACHYCARDIA | Cardiac disorders |
| |||
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders |
| |||
| PYREXIA | General disorders |
| |||
| FATIGUE | General disorders |
| |||
| ANAEMIA | Blood and lymphatic system disorders |
| |||
| PANCYTOPENIA | Blood and lymphatic system disorders |
| |||
| HYPONATRAEMIA | Metabolism and nutrition disorders |
| |||
| BACK PAIN | Musculoskeletal and connective tissue disorders |
| |||
| CONVULSION | Nervous system disorders |
| |||
| SYNCOPE | Nervous system disorders |
| |||
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders |
| |||
| CONSTIPATION | Gastrointestinal disorders |
| |||
| NAUSEA | Gastrointestinal disorders |
| |||
| VOMITING | Gastrointestinal disorders |
| |||
| FATIGUE | General disorders |
| |||
| PYREXIA | General disorders |
| |||
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations |
| |||
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations |
| |||
| BLOOD CREATININE INCREASED | Investigations |
| |||
| ALANINE AMINOTRANSFERASE INCREASED | Investigations |
| |||
| BLOOD BILIRUBIN INCREASED | Investigations |
| |||
| ANAEMIA | Blood and lymphatic system disorders |
| |||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders |
| |||
| NEUTROPENIA | Blood and lymphatic system disorders |
| |||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders |
| |||
| COUGH | Respiratory, thoracic and mediastinal disorders |
| |||
| HYPERTENSION | Vascular disorders |
| |||
| BACK PAIN | Musculoskeletal and connective tissue disorders |
| |||
| HEADACHE | Nervous system disorders |
| |||
| HYPONATRAEMIA | Metabolism and nutrition disorders |
| |||
| DECREASED APPETITE | Metabolism and nutrition disorders |
| |||
| ABDOMINAL PAIN | Gastrointestinal disorders |
| |||
| ABDOMINAL DISTENSION | Gastrointestinal disorders |
| |||
| DYSPEPSIA | Gastrointestinal disorders |
| |||
| OEDEMA PERIPHERAL | General disorders |
| |||
| ASTHENIA | General disorders |
| |||
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations |
| |||
| WHITE BLOOD CELL COUNT DECREASED | Investigations |
| |||
| BLOOD UREA INCREASED | Investigations |
| |||
| NEUTROPHIL COUNT DECREASED | Investigations |
| |||
| HYPOTENSION | Vascular disorders |
| |||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders |
| |||
| MYALGIA | Musculoskeletal and connective tissue disorders |
| |||
| SYNCOPE | Nervous system disorders |
| |||
| HYPOKALAEMIA | Metabolism and nutrition disorders |
| |||
| NIGHT SWEATS | Skin and subcutaneous tissue disorders |
| |||
| PNEUMONIA | Infections and infestations |
| |||
| ANXIETY | Psychiatric disorders |
| |||
| CONFUSIONAL STATE | Psychiatric disorders |
| |||
| RENAL FAILURE ACUTE | Renal and urinary disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernadette Weidman | AstraZeneca | 800-456-3669 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C523665 | fostamatinib |
Not provided
Not provided
Not provided
| Male |
|