| ID | Type | Description | Link |
|---|---|---|---|
| 01-C-0030 |
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Background:
Objectives:
Eligibility:
-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.
Design:
Background:
This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to participants with HIV-associated non-Hodgkin's lymphoma (HIV-NHL).
This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles.
Objective:
To assess with 90 percent probability that at least 50 percent of participants treated with short-course EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will be progression free at one year.
Eligibility:
Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse large B cell lymphoma (DLBCL).
HIV+ serology.
All stages (I-IV) of disease.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-4.
Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy.
Age greater than or equal to 18 years.
May not be pregnant or nursing.
May not have received previous rituximab.
Design:
Participants will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond complete remission (CR)/complete response unconfirmed (CRu) by computed tomography (CT) scan of all detectable tumors for a minimum of three and maximum of six cycles. Following cycle 2, CT, positron emission tomography scans (PET), and bone marrow biopsies (if initially positive) will be performed.
At the conclusion of the study, we will estimate whether the number of cycles can be reduced using the paradigm. If the cumulative number of participants to relapse exceeds 25 percent by 6 months, the study will be closed.
Following the completion of chemotherapy, restaging will be performed 2 months following the end of treatment, then every 3 months for one year, every 6 months for one year, then every 12 months until relapse, death, or loss to follow up.
Antiretroviral therapy (ART) will be given concurrently with treatment regimen.
To study the effects of treatment approach on parameters of HIV disease, measurements of cluster of differentiation 4 (CD4) cells and viral loads will be made at baseline and at the completion of therapy, and then 2 months following the end of treatment, and then every 3-6 months for a total of 24 months following chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | Experimental | Combination chemo and biological therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed. | The participants were followed for a median of 15.4 years. |
| Progression Free Survival at 1 Year | PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity | Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Date treatment consent signed to date off study, approximately 209 months and 17 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible.
Human immunodeficiency virus (HIV) + serology.
All stages (I-IV) of disease.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-4
Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g., epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture
Age greater than or equal to 18 years
Laboratory tests (unless impairment due to respective organ involvement by tumor):
Ability of participant to provide informed consent.
EXCLUSION CRITERIA:
Previous rituximab
Pregnancy or nursing.
- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
Current clinical heart failure or symptomatic ischemic heart disease.
Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R).
Primary CNS lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Max Gordon, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30125215 | Derived | Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20. | |
| 24224624 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
All large-scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol genomic data sharing (GDS) plan for as long as database is active.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1-Combination Chemo and Biological Therapy | Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1-Combination Chemo and Biological Therapy | Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) | PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed. | One participant declined to participate before treatment started. | Posted | Median | 95% Confidence Interval | years | The participants were followed for a median of 15.4 years. |
|
Date treatment consent signed to date off study, approximately 209 months and 17 days.
One participant declined to participate before treatment started.
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 | Arm 1-Combination Chemo and Biological Therapy | Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | General disorders | CTC 2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Max Gordon | National Cancer Institute | 240-858-7151 | max.gordon@nih.gov |
Not provided
| 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 4, 2025 | Dec 12, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2021 | Mar 25, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016483 | Lymphoma, AIDS-Related |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D000163 | Acquired Immunodeficiency Syndrome |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069585 | Filgrastim |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| Filgrastim | Biological | Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle |
|
|
| EPOCH | Drug | combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles |
|
|
| Median Overall Survival | Overall survival is time from treatment start date until date of death or date last known alive. | The participants were followed for survival for a median of 15.4 years. |
| 1 Year Overall Survival | Overall survival is time from treatment start date until date of death or date last known alive. | 1 year |
| Median Duration of Complete Response/Complete Response Unconfirmed | Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR. | The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years. |
| Percentage of Participants With CR/CRu Lasting 1 Year | Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR. | 1 year |
| Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia | Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics. | Date treatment consent signed to date off study, approximately 209 months and 17 days. |
| Number of Cycles of Hematologic Toxicity | Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). | Up to 112 cycles (each cycle is 21 days + 7 days window) |
| Overall Response | Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. | The participants were followed for an average of 6 months to determine response to therapy. |
| Percentage of Participants With Complete Response | Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). | The participants were followed for an average of 6 months to determine response to therapy. |
| Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) | PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival. | Participants were followed for up to 10.2 years to determine their response on interim PET scans. |
| 1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) | 1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans. PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival. | 1 year |
| Recovery of CD4 T Cells (CD4) Counts | Participants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL. | From the end of chemotherapy every 3 months for the first 2 years |
| Recovery of Human Immunodeficiency Virus (HIV) Viral Load | The HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or < 50 copies. | Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 months |
| Date treatment consent signed to date off study, approximately 209 months and 17 days. |
| Derived |
| Dunleavy K, Pittaluga S, Shovlin M, Steinberg SM, Cole D, Grant C, Widemann B, Staudt LM, Jaffe ES, Little RF, Wilson WH. Low-intensity therapy in adults with Burkitt's lymphoma. N Engl J Med. 2013 Nov 14;369(20):1915-25. doi: 10.1056/NEJMoa1308392. |
| Participants |
|
| 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 |
|
|
|
| Primary | Progression Free Survival at 1 Year | PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). | One participant declined to participate before treatment started. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity | Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | One participant declined to participate before treatment started. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 209 months and 17 days. |
|
|
|
| Secondary | Median Overall Survival | Overall survival is time from treatment start date until date of death or date last known alive. | One participant declined to participate before treatment started. | Posted | Median | 95% Confidence Interval | years | The participants were followed for survival for a median of 15.4 years. |
|
|
|
| Secondary | 1 Year Overall Survival | Overall survival is time from treatment start date until date of death or date last known alive. | One participant declined to participate before treatment started. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Median Duration of Complete Response/Complete Response Unconfirmed | Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR. | One participant declined to participate before treatment started. | Posted | Median | 95% Confidence Interval | years | The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years. |
|
|
|
| Secondary | Percentage of Participants With CR/CRu Lasting 1 Year | Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR. | One participant declined to participate before treatment started. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia | Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics. | One participant declined to participate before treatment started. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 209 months and 17 days. |
|
|
|
| Secondary | Number of Cycles of Hematologic Toxicity | Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). | One participant declined to participate before treatment started. | Posted | Number | cycles | Up to 112 cycles (each cycle is 21 days + 7 days window) |
|
|
|
| Secondary | Overall Response | Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. | One participant declined to participate before treatment started, and one participant was not evaluable. | Posted | Count of Participants | Participants | The participants were followed for an average of 6 months to determine response to therapy. |
|
|
|
| Secondary | Percentage of Participants With Complete Response | Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). | One participant declined to participate before treatment started, and one participant was not evaluable. | Posted | Number | percentage of participants | The participants were followed for an average of 6 months to determine response to therapy. |
|
|
|
| Secondary | Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) | PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival. | 27 participants had no PET scan. | Posted | Median | 95% Confidence Interval | years | Participants were followed for up to 10.2 years to determine their response on interim PET scans. |
|
|
|
|
| Secondary | 1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) | 1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans. PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival. | 27 participants had no PET scan. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Recovery of CD4 T Cells (CD4) Counts | Participants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL. | Posted | Median | Full Range | months | From the end of chemotherapy every 3 months for the first 2 years |
|
|
|
| Secondary | Recovery of Human Immunodeficiency Virus (HIV) Viral Load | The HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or < 50 copies. | Posted | Median | Full Range | months | Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 months |
|
|
|
| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | One participant declined to participate before treatment started. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 209 months and 17 days. |
|
|
|
| 12 |
| 67 |
| 23 |
| 67 |
| 66 |
| 67 |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Cardiovascular/Arrhythmia-Other (Asystole) | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| CNS hemorrhage/bleeding | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Constitutional Symptoms-Other (Death- Accident/Overdose) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Creatinine | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Edema | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hemorrhage-Other (alveolar) | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hypophosphatemia | metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Infection without neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Melena/GI bleeding | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Neuropathy - motor | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC 2.0 | Systematic Assessment | Other (Excludes metastasis from initial primary site: B-cell lymphoma) excludes metastasis from initial primary |
|
| Secondary Malignancy-Other (Myelodysplasia/Leukemia) excludes metastasis from initial primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC 2.0 | Systematic Assessment |
|
| Seizure(s) | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Vision-photophobia | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Alkaline phosphatase | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC 2.0 | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTC 2.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Amylase | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Bicarbonate | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Bilirubin | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Bruising (in absence of grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Cardiovascular/Arrhythmia-Other (Tachycardia) | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Chest pain (non-cardiac and non-pleuritic) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Creatinine | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dermatology/Skin-Other (BACTBRABAN) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Dermatology/Skin-Other (Blisters on hands & feet) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Dermatology/Skin-Other (Left leg erythema) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Dermatology/Skin-Other (Erythema derm other) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dizziness/lightheadedness | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Dry eye | Endocrine disorders | CTC 2.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Dyspepsia/heartburn | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dysuria (painful urination) | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Earache (otalgia) | Ear and labyrinth disorders | CTC 2.0 | Systematic Assessment |
|
| Edema | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Erectile impotence | Reproductive system and breast disorders | CTC 2.0 | Systematic Assessment |
|
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Gastrointestinal-Other (Appendicitis-Appendectomy performed) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Gastrointestinal-Other (Fecal incontinence) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hallucinations | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hemorrhage-Other (Hemorrhage, GI) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTC 2.0 | Systematic Assessment |
|
| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Infection | Infections and infestations | CTC 2.0 | Systematic Assessment | (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) |
|
| Infection without neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Infection/Febrile Neutropenia-Other (Infection with Grade 2 neutropenia) | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Inner ear/hearing | Ear and labyrinth disorders | CTC 2.0 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTC 2.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Lipase | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Memory loss | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Mood alteration-anxiety, agitation | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Mood alteration-depression | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Neuropathic pain | Nervous system disorders | CTC 2.0 | Systematic Assessment | (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies) |
|
| Neuropathy-sensory | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Back pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Neck pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Pain -Other (sacral)) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Pain - Other (lower back)) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Tooth pain) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Myositis) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Left leg pain_) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (bone marrow (BM) biopsy site) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (pain behind eye) | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Pain at port site) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Right hip hematoma) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Epigastric pain) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Leg and back pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Back) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Generalized) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Tooth abscess) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Pain-Other (Mild left side plank pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Partial thromboplastin time (PTT) | Investigations | CTC 2.0 | Systematic Assessment |
|
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Prothrombin time (PT) | Investigations | CTC 2.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Rectal bleeding/hematochezia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Rectal or perirectal pain (proctalgia) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Renal/Genitourinary-Other (Vaginal blisters) | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Rigors, chills | General disorders | CTC 2.0 | Systematic Assessment |
|
| Seizure(s) | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTC 2.0 | Systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Tearing (watery eyes) | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Thrombosis/embolism | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Transfusion: Platelets | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Transfusion: pRBCs | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Tumor lysis syndrome | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC 2.0 | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Vision-flashing lights/floaters | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Vision-photophobia | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Weight gain | General disorders | CTC 2.0 | Systematic Assessment |
|
| Weight loss | General disorders | CTC 2.0 | Systematic Assessment |
|
Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| Title | Measurements |
|---|---|
|
| Syncope |
|
| Confusion |
|
| Motor neuropathy |
|
| Vision disturbance |
|
| Hyperglycemia |
|
| Hypophosphatemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Dehydration |
|
| Mucositis/Stomatitis |
|
| Liver test abnormalities |
|
| Pancreatitis |
|
| Diarrhea |
|
| Constipation |
|
| Serious hemorrhage |
|
| Fatigue |
|
| Headache |
|
| Bone pain |
|
| Nausea |
|
| Anorexia |
|
| Hypoxia |
|
| Myelodysplastic syndrome |
|
| Title | Measurements |
|---|---|
|
| Thrombocytopenia with a Nadir <50,000 platelets/mm^3 |
|
| Thrombocytopenia with a Nadir <25,000 platelets/mm^3 |
|
| Anemia: hemoglobin <8 g/dL |
|
| Title | Measurements |
|---|---|
|
| Non-Responder - Stable Disease |
|
| Non-Responder - Progressive Disease |
|
|
|