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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0410 | Other Identifier | SWOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy. No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell collection.
Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study.
Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy. All patients then proceed to the first preparative regimen.
First preparative regimen: Patients receive high-dose melphalan IV on day -1.
First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. At least 28 days later, patients proceed to second preparative regimen.
Second preparative regimen: Patients receive 1 of the following preparative regimens:
Second autologous SCT: Patients undergo second autologous SCT on day 0. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 7 years.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose therapy plus tandem transplant | Experimental | Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carmustine | Drug | 150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-free Survival | Measured from date of randomization to date of first observation of progressive disease, or death due to any cause | At day 60, then every 6 months for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed Hodgkin's lymphoma
Has received ≥ 1 prior systemic chemotherapy regimen
No clonal abnormalities in marrow collection
Must undergo involved-field radiotherapy if bulky disease > 5 cm
Must have adequate sections of original diagnostic specimen available for review
No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free > 5 years)
Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present
No central nervous system (CNS) involvement
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following conditions requiring therapy:
Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Eileen P. Smith, MD | City of Hope Medical Center | Study Chair |
| Patrick J. Stiff, MD | Loyola University | Study Chair |
| Louis S. Constine, MD | James P. Wilmot Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States | ||
| Mountain States Tumor Institute at St. Luke's Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29289757 | Derived | Smith EP, Li H, Friedberg JW, Constine LS, Rimsza LM, Cook JR, Laport GG, Popplewell LL, Holmberg LA, Smith SM, LeBlanc M, Forman SJ, Fisher RI, Stiff PJ. Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703). Biol Blood Marrow Transplant. 2018 Apr;24(4):700-707. doi: 10.1016/j.bbmt.2017.12.798. Epub 2017 Dec 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Therapy Plus Tandem Transplant | Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cyclophosphamide | Drug | 100 mg/kg IV 2 days before transplant. |
|
| etoposide | Drug | 60 mg/kg IV over 4 hours 4 days before transplant. |
|
| melphalan | Drug | 150 mg/m^2 IV 1 day before transplant. |
|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | 2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion. |
|
| radiation therapy | Radiation | 150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant. |
|
|
| At day 60, then every 6 months for 2 years |
| Overall Survival | Measured from date of registration to date of death due to any cause or last contact | At day 60, then every 6 months for 2 years, then annually for a total of 7 years |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion |
| Boise |
| Idaho |
| 83712 |
| United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon | 97210 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| Adventist Medical Center | Portland | Oregon | 97216 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Auburn Regional Center for Cancer Care | Auburn | Washington | 98002 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Providence Centralia Hospital | Centralia | Washington | 98531-9027 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506-5166 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Polyclinic First Hill | Seattle | Washington | 98122 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| Eligible |
|
| Eligible and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose Therapy Plus Tandem Transplant | Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 2-year Progression-free Survival | Measured from date of randomization to date of first observation of progressive disease, or death due to any cause | All eligible patients who started treatment were included in the analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At day 60, then every 6 months for 2 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Response Rate | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. | All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded. | Posted | Number | participants | At day 60, then every 6 months for 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Measured from date of registration to date of death due to any cause or last contact | All eligible patients who started treatment were included in the analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At day 60, then every 6 months for 2 years, then annually for a total of 7 years |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. | Posted | Number | Participants | Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion |
|
|
Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose Therapy Plus Tandem Transplant | Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. | 2 | 90 | 88 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual-Other (Specify) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal-Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Face | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other (Specify) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-Other (Specify) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Cholesterol, serum-high (hypercholesterolemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| GGT (gamma-glutamyl transpeptidase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-Other (Specify) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, not d/t neuropathy - body/general | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual-Other (Specify) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU - Urinary NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary-Other (Specify) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU - Vagina | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-Other (Specify) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin-Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage/Bleeding-Other (Specify) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes/flushes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lymphoma Committee Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D011878 | Radiotherapy |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|