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This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.
Brentuximab vedotin will be administered as an outpatient IV infusion on day 1 of each 21-day cycle. Bendamustine will be given as an outpatient infusion on days 1 and 2 of a 21-day cycle. Patients may receive prophylactic pegfilgrastim on day 3 of each cycle, or filgrastim for 5 to 10 days, per investigator's discretion. Patients can receive a maximum of 6 cycles of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin / Bendamustine | Experimental | Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive Brentuximab Vedotin in combination with Bendamustine, and prophylactic Neulasta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1) | This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine. | 21 days |
| Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1) | This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine. | 21 days |
| Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1 | DLT is defined as any missed dose within cycle 1 or toxicity that was possibly related to the study drug occurring up to 7 days after completion of cycle 1 that resulted in a delay of initiation of cycle 2; grade 4 neutropenia that did not resolve to grade 2 or lower within 7 days; grade 4 thrombocytopenia lasting more than 7 days; grade 3 febrile neutropenia (absolute neutrophil count of <1000 cells per μL with a single temperature of >38·3°C or a sustained temperature of ≥38°C for >1 h); and any grade 3 or worse non-haematological toxicity, with the specific exception of nausea, vomiting, diarrhoea, or dehydration lasting for more than 48 h in the setting of inadequate compliance with supportive care measures or grade 3 hypercholesterolaemia, hypertriglyceridaemia, constipation, or fatigue. | 21 days |
| Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine | The number of subjects whose cancer shrinks or disappears after study treatment | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) in Phase 1 | Duration of response is defined as the time from documentation of a response to treatment to the first documentation of tumor progression, or death from any cause, whichever occurred first. | Up to 50 months |
| Progression Free Survival (PFS) in Phase 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Tarc Levels | This is designed to measure the response to study treatment if the level declines. | Up to 3 years |
| Level of Peripheral Blood Lymphocyte Expression of Programmed Death-1 (PD-1) | The level will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine. |
Inclusion Criteria:
Histologically confirmed relapsed or refractory HL or ALCL.
Documented CD30+ expression from either original diagnosis or a tumor biopsy in the relapsed setting.
For patients with HL, subjects are eligible after failure or having declined autologous stem cell transplant or at least two prior multi-agent chemotherapy regimens if they are not autologous stem cell transplant candidates. For patients with ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen and if they are not eligible for or have declined autologous stem cell transplant.
Must have received first line chemotherapy. No upper limit for the number of prior therapies.
Patients with prior autologous or allogeneic stem cell transplant are eligible as long as they meet all other criteria.
Measurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma(33)
Age > or = 18 years
ECOG performance status 0,1 or 2
Patient's must have adequate organ and marrow function as defined below
If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study
Must be willing to use contraception during the study, and for 30 days following the last dose of study drug.
Able to understand and to sign a written consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Owen A O'Connor, MD, Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Lymphoid Malignancies at CUMC | New York | New York | 10010 | United States | ||
| British Columbia Cancer Agency |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29276022 | Derived | O'Connor OA, Lue JK, Sawas A, Amengual JE, Deng C, Kalac M, Falchi L, Marchi E, Turenne I, Lichtenstein R, Rojas C, Francescone M, Schwartz L, Cheng B, Savage KJ, Villa D, Crump M, Prica A, Kukreti V, Cremers S, Connors JM, Kuruvilla J. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol. 2018 Feb;19(2):257-266. doi: 10.1016/S1470-2045(17)30912-9. Epub 2017 Dec 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2 | Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2015 |
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|
| Bendamustine | Drug | Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle. |
|
|
| Neulasta | Drug | (Non-experimental) Standard procedure prophylactic pegfilgrastim on day 3 of any subsequent cycle after cycle 1, or filgrastim for 5 to 10 days, per investigator's discretion. |
|
|
The length of time during and after the study treatment that a subject lives with the disease but it does not get worse. |
| Up to 50 months |
| Overall Survival (OS) in Phase 1 | The length of time from either the date of diagnosis or the start of study treatment that subjects diagnosed with the disease are still alive. | Up to 50 months |
| Up to 3 years |
| Decline in Serum Levels of IL-10 and IL-6 | The decline will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine. | Up to 3 years |
| Vancouver |
| British Columbia |
| V5z 4E6 |
| Canada |
| Princess Margaret Hospital | Toronto | Ontario | Canada |
| FG001 | Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2 | Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| FG002 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 | Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| FG003 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| FG004 | Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Brentuximab Vedotin1.2 mg/kg, Bendamustine 70mg/m^2 | Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| BG001 | Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2 | Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| BG002 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 | Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| BG003 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| BG004 | Phase 2 | Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| BG005 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1) | This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine. | This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here. | Posted | Number | mg/kg | 21 days |
|
|
| ||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1) | This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine. | This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here. | Posted | Number | mg/m2 | 21 days |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1 | DLT is defined as any missed dose within cycle 1 or toxicity that was possibly related to the study drug occurring up to 7 days after completion of cycle 1 that resulted in a delay of initiation of cycle 2; grade 4 neutropenia that did not resolve to grade 2 or lower within 7 days; grade 4 thrombocytopenia lasting more than 7 days; grade 3 febrile neutropenia (absolute neutrophil count of <1000 cells per μL with a single temperature of >38·3°C or a sustained temperature of ≥38°C for >1 h); and any grade 3 or worse non-haematological toxicity, with the specific exception of nausea, vomiting, diarrhoea, or dehydration lasting for more than 48 h in the setting of inadequate compliance with supportive care measures or grade 3 hypercholesterolaemia, hypertriglyceridaemia, constipation, or fatigue. | Posted | Count of Participants | Participants | 21 days |
| |||||||||||||||||||||||||||||
| Primary | Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine | The number of subjects whose cancer shrinks or disappears after study treatment | Posted | Count of Participants | Participants | Up to 3 years |
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) in Phase 1 | Duration of response is defined as the time from documentation of a response to treatment to the first documentation of tumor progression, or death from any cause, whichever occurred first. | Pre-specified to report all Phase 1 data as a single Arm | Posted | Median | 95% Confidence Interval | months | Up to 50 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) in Phase 1 | The length of time during and after the study treatment that a subject lives with the disease but it does not get worse. | Pre-specified to report all Phase 1 data as a single Arm | Posted | Median | 95% Confidence Interval | months | Up to 50 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Phase 1 | The length of time from either the date of diagnosis or the start of study treatment that subjects diagnosed with the disease are still alive. | Pre-specified to report all Phase 1 data as a single Arm | Posted | Median | 95% Confidence Interval | months | Up to 50 months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Serum Tarc Levels | This is designed to measure the response to study treatment if the level declines. | Investigator has left the institution. No data was available or analyzed. | Posted | Up to 3 years |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Level of Peripheral Blood Lymphocyte Expression of Programmed Death-1 (PD-1) | The level will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine. | Investigator has left the institution. No data was available or analyzed. | Posted | Up to 3 years |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Decline in Serum Levels of IL-10 and IL-6 | The decline will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine. | Investigator has left the institution. No data was available or analyzed. | Posted | Up to 3 years |
|
|
Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
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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 | Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2 | Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. | 6 | 7 | 3 | 7 | 7 | 7 |
| EG001 | Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2 | Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 | Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. | 2 | 7 | 2 | 7 | 7 | 7 |
| EG003 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. | 6 | 11 | 5 | 11 | 11 | 11 |
| EG004 | Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. | 7 | 37 | 12 | 37 | 35 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| CMV Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Immune system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Kidney infection | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| myelosuppression | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| nausea grade 3 | General disorders | Systematic Assessment |
| ||
| staphylococcal bacteremia | Infections and infestations | Systematic Assessment |
| ||
| vomiting grade 2 | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Immune system disorders | Systematic Assessment |
| ||
| Alopecia | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | General disorders | Systematic Assessment |
| ||
| Anxiety | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Immune system disorders | Systematic Assessment |
| ||
| Back pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Confusion | General disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | General disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Dry mouth | General disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | General disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Epistaxis | Vascular disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Flushing | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Hot flashes | General disorders | Systematic Assessment |
| ||
| Hyperglycemia | General disorders | Systematic Assessment |
| ||
| Hyperhidrosis | General disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hyponatremia | General disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Infusion related reaction | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | General disorders | Systematic Assessment |
| ||
| Lymphedema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Mucositis oral | General disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasal congestion | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pain in extremity | General disorders | Systematic Assessment |
| ||
| Paresthesia | General disorders | Systematic Assessment |
| ||
| Pelvic pain | General disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Phlebitis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus | General disorders | Systematic Assessment |
| ||
| Rash | General disorders | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Sore throat | General disorders | Systematic Assessment |
| ||
| Stomach pain | General disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Toothache | General disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Vomiting | General disorders | Systematic Assessment |
| ||
| tachycardia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Ignat | Columbia University | 212-305-3612 | ai2111@cumc.columbia.edu |
| Apr 27, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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 |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D000069461 | Bendamustine Hydrochloride |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
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| OG002 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 | Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| OG003 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
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| OG003 | Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
| OG004 | Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 | Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes. |
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