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| Name | Class |
|---|---|
| Cephalon | INDUSTRY |
The standard treatment for patients with HL that has not responded to treatment or has come back after treatment is stem cell transplant. When patients are not eligible for transplant or when HL comes back after transplant, there are no standard treatment options. These patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a chemotherapy agent that is effective in treating patients with various diseases, including non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe have shown that bendamustine HCl is likely effective for treating HL. This study will find out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not responded to or has come back after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | bendamustine hcl 120mg/m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine hcl | Drug | Patients will receive bendamustine 120mg/m^2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL. | The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Moskowitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23248254 | Derived | Moskowitz AJ, Hamlin PA Jr, Perales MA, Gerecitano J, Horwitz SM, Matasar MJ, Noy A, Palomba ML, Portlock CS, Straus DJ, Graustein T, Zelenetz AD, Moskowitz CH. Phase II study of bendamustine in relapsed and refractory Hodgkin lymphoma. J Clin Oncol. 2013 Feb 1;31(4):456-60. doi: 10.1200/JCO.2012.45.3308. Epub 2012 Dec 17. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL. | The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. | Posted | Number | percentage of evaluable participants | up to 3 years |
|
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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 | All Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Moskowitz, MD | Memorial Sloan Kettering Cancer Center | (212) 639-7992 | moskowic@mskcc.org |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 5 |
| 36 |
| 36 |
| 36 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Self-limited Gross Hematuria | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTC-3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Fever | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pneumonia | General disorders | CTC-3.0 | Systematic Assessment |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Febrile Neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
|
| Hematuria | General disorders | CTC-3.0 | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| 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 |