Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| E1902 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) | |
| U10CA021115 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
OBJECTIVES:
OUTLINE: This is a single-arm, two-stage, multicenter phase II study.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients would be accrued for this study within 2.1 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Immunosuppressant |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Developed Disease Progression After Achieving Complete Response | Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here. |
Not provided
Inclusion Criteria:
One of the following cytologically proven myelodysplastic syndromes
International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available
Patients must have < 20% blasts on bone marrow study within 1 month of study entry
Age of 18 to 70 years
Eastern Cooperative Oncology Group performance status 0-1
Life expectancy at least 6 months
At least 90 days since prior autologous bone marrow transplantation
Serum erythropoietin level greater than 100 for patients who have not received a prior course of epoetin alfa
No iron deficiency
Bilirubin less than 2.0 mg/dL
Alkaline phosphatase less than 2 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times ULN
Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
Left ventricular ejection fraction (LVEF) at least 45% by Multigated Acquisition scan (MUGA) or echocardiogram
Carbon Monoxide Diffusing Capacity (DLCO) at least 50% of predicted (corrected for hemoglobin)
Forced expiratory volume in 1 second (FEV_1) at least 50% of predicted
Recovered from prior chemotherapy
Physically and psychologically capable of undergoing study regimen
Able to receive 600 cGy of total body irradiation
HIV negative
Negative pregnancy test
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selina M. Luger, MD | Abramson Cancer Center at Penn Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
Not provided
This trial was open to accrual on May 18, 2005 with the first patient accrued on October 24, 2006. By September 23, 2009, 17 patients were enrolled to the trial and the first 15 patients were included in the interim analysis. This trial did not meet pre-defined criteria to continue to the second stage. In the end, a total of 17 patients were enrolled to the trial from 7 participating institutions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methotrexate | Drug | Antimetabolite |
|
|
| Photopheresis | Drug | Psoralens |
|
|
| Mycofenolate mofetil | Drug | an antibiotic with immunosuppressamt properties isolated from Penicillium spp |
|
|
| Pentostatin | Drug | Purine analogue |
|
|
| allogeneic bone marrow | Procedure | Unmanipulated allogeneic bone marrow |
|
| peripheral blood stem cell | Procedure | G-CSF mobilized peripheral blood stem cell |
|
| Total body irradiation | Radiation | a total of 600 cGy given in 3 200 cGy fractionated doses |
|
|
| Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| Overall Survival | Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS. | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| Proportion of Graft Versus Host Disease | Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| Time to Engraftment for Neutrophil | Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3. | Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100. |
| Time to Engraftment for Platelet | Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000. | Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100. |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Tufts-NEMC Cancer Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Jewish Hospital Cancer Center | Cincinnati | Ohio | 45236 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Eligible and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
eligible and treated patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. |
| 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 |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Complete Response Rate | Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present | eligible and treated patients | Posted | Number | 90% Confidence Interval | percentage of participants | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Patients Who Developed Disease Progression After Achieving Complete Response | Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here. | eligible and treated patients who achieved complete response | Posted | Number | participants | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS. | eligible and treated patients | Posted | Median | 95% Confidence Interval | years | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| |||||||||||||||||||||||||||
| Secondary | Proportion of Graft Versus Host Disease | Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients | eligible and treated patients | Posted | Number | 95% Confidence Interval | proportion of participants | Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5. |
| |||||||||||||||||||||||||||
| Secondary | Time to Engraftment for Neutrophil | Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3. | eligible and treated patients | Posted | Median | 95% Confidence Interval | days | Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100. |
| |||||||||||||||||||||||||||
| Secondary | Time to Engraftment for Platelet | Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000. | eligible and treated patients | Posted | Median | 95% Confidence Interval | days | Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100. |
|
Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
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 I | Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. | 17 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Infections and infestations - Other, spe | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Infections and infestations - Other, spe | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal di | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| External ear inflammation | Ear and labyrinth disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Infections and infestations - Other, spe | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Edema trunk | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE 3.0 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal di | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 3.0 | Systematic Assessment |
| |
| General disorders and administration sit | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D000753 | Anemia, Refractory |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000740 | Anemia |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D008727 | Methotrexate |
| C015342 | merphos |
| D017893 | Photopheresis |
| D008730 | Methoxsalen |
| D009173 | Mycophenolic Acid |
| D015649 | Pentostatin |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003070 | Coformycin |
| D005573 | Formycins |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D008919 | Investigative Techniques |
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