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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03090 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STU00072695 | Other Identifier | Northwestern University IRB# |
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Lack of funding
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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
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The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients
PRIMARY OBJECTIVES:
I. To evaluate the safety of brentuximab vedotin and rituximab in patients with lymphoid malignancies that are cluster of differentiation (CD) 30 positive (+) and/or Epstein-Barr virus (EBV)+, and to determine the recommended phase 2 dose (RP2D) of the combination. (Phase I) II. To evaluate the efficacy, as measured by response rates, of brentuximab vedotin and rituximab in patients with lymphoid malignancies that are CD30+ and/or EBV+. (Phase II)
SECONDARY OBJECTIVES:
I. To further evaluate the frequency and severity of toxicity. (Phase II) II. To further evaluate the clinical efficacy of the combination of brentuximab vedotin and rituximab, as measured by progression free survival (PFS) and overall survival (OS) at one year after the end of treatment. (Phase II) III. To determine the effects of the combination of brentuximab vedotin and rituximab on markers of EBV activation and proliferation. (Phase II) IV. Further evaluate efficacy as measured by time to cytotoxic chemotherapy. (Phase II) V. Further evaluate efficacy as measured by observed rates of graft rejection. (Phase II)
TERTIARY OBJECTIVES:
I. To determine whether and to what extent CD30 expression predicts for response and outcome.
II. To determine whether and to what extent expression of EBV markers predicts for response and outcome.
III. To determine whether changes in serum levels of EBV correlate with response and subsequent loss of response to therapy.
OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study.
INDUCTION: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes once weekly for 3 weeks and rituximab IV once weekly for 4 weeks. Patients unable to achieve complete remission (CR) may receive additional optional consolidation therapy identical to induction therapy.
MAINTENANCE THERAPY: Patients receive brentuximab vedotin IV once every 3 weeks and rituximab IV once every 6 weeks. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (brentuximab vedotin, rituximab) | Experimental | INDUCTION: Patients receive brentuximab vedotin IV over 30 minutes once weekly for 3 weeks and rituximab IV once weekly for 4 weeks. Patients unable to achieve CR may receive additional optional consolidation therapy identical to induction therapy. MAINTENANCE THERAPY: Patients receive brentuximab vedotin IV once every 3 weeks and rituximab IV once every 6 weeks. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab. | To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in <2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose) 1.2 mg/kg IV, and Level -1 (de-escalation dose): 0.8 mg/kg IV. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. | The first 21 days of Induction |
| Phase 1: Number of Dose Limiting Toxicities of Brentuximab Vedotin and Rituximab in Patients With Immunosuppressed Lymphoid Malignancies. | Dose limiting toxicities (DLT) will be monitored for Phase 1 patients for the first 21 days of Induction (the DLT monitoring period) to evaluate safety. In general, a non-hematologic DLT is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v4.03 criteria. | The first 21 days of induction |
| Phase II: Percent of Participants With an Overall Response | Overall response will be defined as the detection of Partial Response (PR) or Complete Response (CR) by CT or PET/CT, and/or resolution of marrow-only involvement. Response will be assessed according to the Revised Response Criteria for Malignant Lymphoma (Cheson, et al). CR is defined as a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. A PR is defined as At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 | Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death. |
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Inclusion Criteria:
Histologically confirmed CD30+ and/or EBV+ lymphoid malignancy; in addition, there must be evidence of CD20 expression (at any level)
In cases of post-transplant lymphoproliferative disorder (PTLD) arising in patients who are pharmacologically immunosuppressed, reduction of immunosuppression (RI) must be attempted prior to or in conjunction with enrollment, with the exception of those for whom RI would pose excessive threat of clinically significant graft rejection (as judged by local investigator)
No prior chemotherapy or radiotherapy for PTLD or diffuse large B-cell lymphoma (DLBCL), with the exception of corticosteroids for 10 or fewer days at any dose (no washout period required)
No prior surgical intervention, unless performed for the sake of tissue diagnosis or on an urgent basis for disease-related threat to life, limb, or organ function
Bi-dimensionally measurable disease (at least 1 cm)
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Absolute neutrophil count >= 750/mcL
Platelets >= 50,000/mcl
Total bilirubin =< 2 X institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum pyruvate glutamate transaminase [SPGT]) =< 3 X institutional ULN
Creatinine =< 2 X institutional ULN
NOTE: Patients who do not meet the above criteria because of disease involvement of the organ in question, or because of acute systemic illness due to lymphoma, may enroll with permission of the study Principal Investigator (PI) and approval from the Data Monitoring Committee; this flexibility be allowed due to the heterogeneity of the patient population, the wide range of complications seen in the initial presentation of EBV-related malignancy, and the frequent difficulty encountered in attempting to clearly document that organ dysfunction is the result of an underlying lymphoproliferative disorder
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Patients must be free of any prior malignancies for >= 1 year; NOTE: the exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excision; in addition, it is well-recognized that patients at highest risk for EBV-related lymphoma (ie, those with chronic immunosuppression) are also at high risk for various malignancies, both invasive and non-invasive; therefore, exceptions may also be granted on a case-by-case basis, at the discretion of the PI with approval from the Data Monitoring Committee, for those patients with good clinical control of active malignancy, if the EBV-related lymphoma is considered to be a more immediate threat to the subject's health and/or life
Ability to understand and the willingness to sign a written informed consent; all patients must have signed, witnessed informed consent prior to registration
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Petrich, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Chicago |
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The study opened for accrual on March 4th, 2013 with goal of up to 33 patients. The 1st patient started treatment in Phase 1 on March 5th, 2013. 6 patients were accrued in Phase 1. March 26th, 2014 the study opened to Phase II, 14 patients were accrued. October 29th, 2018 the study closed due to lack of funding.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin Dose Level -1 (0.8 mg/kg) | Treatment: Induction:
Consolidation (optional): Identical to Induction. Maintenance: Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction (4 Weeks) |
|
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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 | Sep 24, 2018 |
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| rituximab | Biological | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
| From time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
| Percentage of Participants Without Progression (Progression Free Survival (PFS)) | Study treatment efficacy will be evaluated using PET or CT scan images to determine Progression Free Survival (PFS). PFS is defined as the duration of time from start of treatment to time of progression. Response criteria will be those specified by Cheson, et al as the Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD) is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size, or at least a 50% increase from nadir in the diameter of any previously involved nodes, or in a single involved node, or the size of other lesions. All patients who have had at least one dose of study treatment will be evaluable for PFS with censoring of patients who are lost to follow-up. PFS will be reported as percentage of participants without progression. | start of treatment to time of progression (up to 2 years after treatment discontinuation) |
| Percentage of Participants Alive at 2 Years (Overall Survival) | Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up. | From start of treatment to 2 years post treatment discontinuation |
| Number of Participants With Best Overall Response (BOR) | The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression/recurrence. Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion > 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes. | Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
| Number of Participants With Epstein Barr Virus (EBV) Activation and Number of Participants Without EBV Activation | EBV activation will be evaluated in all patients who receive at least one dose of study treatment and have an evaluable tissue microarray (TMA) collected at baseline. EBV activation and proliferation will be measured by viral loads from blood collections as measured at time of enrollment and monthly thereafter in all enrolled patients, until completion of study therapy. Epstein Barr Virus (EBV) quantitative PCR is used to an aid in monitoring EBV-related disease. Lab thresholds vary at sites however, labs results are considered either "negative" or "abnormal". Number of participants who experienced EBV activation, i.e an abnormal lab result (YES) and patients who did not experience EBV activation, i.e. a negative lab result (NO) will be reported. | Time from start of study treatment to last dose of study drug (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles, up to 1 year) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
| Time to Initiation of Cytotoxic Chemotherapy | Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment. | Up to 3 years from treatment discontinuation |
| Number of Participants With Graft Rejection vs Without Graft Rejection | Graft rejection will be defined as any of the following: documentation of new or progressive rejection by tissue biopsy of the graft; re-transplantation due to graft rejection; clinical diagnosis of new or progressive graft rejection, since start of treatment on protocol, as given by the patient's transplant physician. Escalation of intensity of immunosuppression will not, by itself, be considered evidence of graft rejection. Note: patients with clinically active graft rejection will not be excluded from trial enrollment, but will not be considered to have treatment emergent graft rejection unless progression of rejection is documented. Rates of graft rejection will be evaluated in all patients who receive at least one dose of study treatment. | From start of treatment to 3 years post treatment discontinuation |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| FG001 | Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) | Induction:
Consolidation (optional): Identical to Induction. Maintenance:
|
| Received Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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| Consolidation (Optional, 4 Weeks) |
|
| 1st Cycle of Maintenance (3 Weeks) |
|
|
| 2nd Cycle of Maintenance and Beyond |
|
|
| Follow Up (up to 3 Years) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) | Induction:
Consolidation (optional): Identical to Induction. Maintenance:
|
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab. | To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in <2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose) 1.2 mg/kg IV, and Level -1 (de-escalation dose): 0.8 mg/kg IV. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. | Posted | Number | mg/kg | The first 21 days of Induction |
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| Primary | Phase 1: Number of Dose Limiting Toxicities of Brentuximab Vedotin and Rituximab in Patients With Immunosuppressed Lymphoid Malignancies. | Dose limiting toxicities (DLT) will be monitored for Phase 1 patients for the first 21 days of Induction (the DLT monitoring period) to evaluate safety. In general, a non-hematologic DLT is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v4.03 criteria. | Six patients in Phase 1 received dose level 1 of brentuximab vedotin (1.2 mg/kg IV). | Posted | Number | Grade 3 hyponatremia | The first 21 days of induction |
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| Primary | Phase II: Percent of Participants With an Overall Response | Overall response will be defined as the detection of Partial Response (PR) or Complete Response (CR) by CT or PET/CT, and/or resolution of marrow-only involvement. Response will be assessed according to the Revised Response Criteria for Malignant Lymphoma (Cheson, et al). CR is defined as a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. A PR is defined as At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. | Posted | Number | 95% Confidence Interval | percent of participants | Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
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| Secondary | Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 | Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death. | Posted | Count of Participants | Participants | From time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
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| Secondary | Percentage of Participants Without Progression (Progression Free Survival (PFS)) | Study treatment efficacy will be evaluated using PET or CT scan images to determine Progression Free Survival (PFS). PFS is defined as the duration of time from start of treatment to time of progression. Response criteria will be those specified by Cheson, et al as the Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD) is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size, or at least a 50% increase from nadir in the diameter of any previously involved nodes, or in a single involved node, or the size of other lesions. All patients who have had at least one dose of study treatment will be evaluable for PFS with censoring of patients who are lost to follow-up. PFS will be reported as percentage of participants without progression. | One patient was excluded from the analysis because they were lost to follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | start of treatment to time of progression (up to 2 years after treatment discontinuation) |
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| Secondary | Percentage of Participants Alive at 2 Years (Overall Survival) | Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up. | One patient was censored from overall survival because they were lost to follow-up. | Posted | Number | 90% Confidence Interval | percent of participants | From start of treatment to 2 years post treatment discontinuation |
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| Secondary | Number of Participants With Best Overall Response (BOR) | The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression/recurrence. Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion > 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes. | Posted | Number | participants | Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
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| Secondary | Number of Participants With Epstein Barr Virus (EBV) Activation and Number of Participants Without EBV Activation | EBV activation will be evaluated in all patients who receive at least one dose of study treatment and have an evaluable tissue microarray (TMA) collected at baseline. EBV activation and proliferation will be measured by viral loads from blood collections as measured at time of enrollment and monthly thereafter in all enrolled patients, until completion of study therapy. Epstein Barr Virus (EBV) quantitative PCR is used to an aid in monitoring EBV-related disease. Lab thresholds vary at sites however, labs results are considered either "negative" or "abnormal". Number of participants who experienced EBV activation, i.e an abnormal lab result (YES) and patients who did not experience EBV activation, i.e. a negative lab result (NO) will be reported. | 1 patient was not evaluable. They withdrew consent before data could be collected. | Posted | Number | participants | Time from start of study treatment to last dose of study drug (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles, up to 1 year) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
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| Secondary | Time to Initiation of Cytotoxic Chemotherapy | Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment. | Follow-up data for time to initiation of cytotoxic chemotherapy was collected for only 5 patients. That data is reported below. | Posted | Number | number of days | Up to 3 years from treatment discontinuation |
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| Secondary | Number of Participants With Graft Rejection vs Without Graft Rejection | Graft rejection will be defined as any of the following: documentation of new or progressive rejection by tissue biopsy of the graft; re-transplantation due to graft rejection; clinical diagnosis of new or progressive graft rejection, since start of treatment on protocol, as given by the patient's transplant physician. Escalation of intensity of immunosuppression will not, by itself, be considered evidence of graft rejection. Note: patients with clinically active graft rejection will not be excluded from trial enrollment, but will not be considered to have treatment emergent graft rejection unless progression of rejection is documented. Rates of graft rejection will be evaluated in all patients who receive at least one dose of study treatment. | 1 patient was not evaluable. They withdrew consent before data could be collected. | Posted | Number | participants | From start of treatment to 3 years post treatment discontinuation |
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| Post-Hoc | Median Time to Best Response | Time to best response = the number of days from treatment initiation to best response (complete response/CR or partial response/PR). Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion > 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes. | Posted | Median | Full Range | number of days | From start of treatment, every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks |
|
Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance).
Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
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 | Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) | Induction:
Consolidation (optional): Identical to Induction. Maintenance:
| 2 | 20 | 14 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment | 1 patient also experienced dyspena and chest pain at the time of this event. 1 patient also experienced upper respiratory infection at the time of this event. |
|
| Neutrophil count decreased | Investigations | CTCAE 4.03 | Systematic Assessment | 1 patient also experienced fever at the time of this event. |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment | 1 patient also experienced chills and malaise at the time of this event. |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.03 | Systematic Assessment | 1 patient also experienced a decrease in neutrophil count at the time of this event. |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment | This patient also experienced hyperglycemia, pneumonia, drug-induced liver injury, and catheter-associated urinary tract infection at the time of this event. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Heart murmur | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Eye pain | Eye disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abnormal satiety | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Night sweats | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Irritability | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | Immune system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Swollen ankle | Injury, poisoning and procedural complications | CTCAE 4.03 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sessile polyp in descending colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.03 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Altered mental state | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Elevated liver enzymes | Hepatobiliary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Benign paroxysmal positional vertigo | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Difficulty with fine motor skills | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Restless leg syndrome | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Increase urinary frequency | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Malodorous urine | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Low glomerular filtration rate | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Renal tubulitis | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Catheter associated urinary tract infection | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Polyp underneath eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.03 | Systematic Assessment |
| |
| Platelet count increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Abnormal Blood Urea Nitrogen | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Increased Lactate Dehydrogenase | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Decreased monocytes | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Generalized body soreness | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Muscle twinges in legs, abdomen, and chest | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Left shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypovolemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Low iron | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Lactic Acidosis | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Mouth sores | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Worsening of right lung opacity in CT scan | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Shortness of breath with exertion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Itching of medial portion of the knees | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| tender back | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| redness of left leg | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Cellulitis behind ear | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
The study did not meet it's accrual goal of 33 patients. The study closed due to lack of funding.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Pro, MD | Northwestern University, Feinberg School of Medicine | 312-695-6180 | barbara.pro@northwestern.edu |
| Jun 25, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D020031 | Epstein-Barr Virus Infections |
| D064090 | Intraocular Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D002051 | Burkitt Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007943 | Leukemia, Hairy Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| 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 |
| D000072281 | Lymphadenopathy |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D000069283 | Rituximab |
| 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 |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
Not provided
Not provided
| Adverse Event |
|
| Death |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
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