Not provided
Not provided
Not provided
Not provided
Not provided
Unable to accrue patients due to change in standard CLL therapy
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Cephalon | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab and Bendamustine | Experimental | Ofatumumab and Bendamustine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab and Bendamustine | Drug | Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | NCI IWG response criteria | 6 months |
| Median PFS | Kaplan Meyer PFS | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce Cheson, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24925211 | Derived | Ujjani C, Ramzi P, Gehan E, Wang H, Wang Y, Cheson BD. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015 Apr;56(4):915-20. doi: 10.3109/10428194.2014.933217. Epub 2014 Aug 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ofatumumab and Bendamustine | Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ofatumumab and Bendamustine | Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles |
| 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 |
| 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 | Overall Response Rate | 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia | Posted | Number | participants | 6 months |
|
|
1 year
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 | Ofatumumab and Bendamustine | Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce D. Cheson | Georgetown University Hospital | 202-444-1212 | bdc4@georgetown.edu |
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C527517 | ofatumumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Complete Response Rate | NCI IWG response criteria | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Median PFS | Kaplan Meyer PFS | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| 3 |
| 10 |
| 9 |
| 10 |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Allergy/infusion reaction | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |