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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E1900 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to induction therapy (standard-dose daunorubicin vs high-dose daunorubicin).
Induction therapy: Patients are randomized to 1 of 2 induction arms.
Patients in both arms may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. The second course is administered as in arm I to all patients. Patients who don't achieve CR after 2 courses of induction therapy are removed from study.
Patients who achieve CR after induction therapy proceed to post-remission therapy with EITHER allogeneic transplantation only (on or off study) OR consolidation therapy and autologous transplantation (on study), according to risk status and donor status.
Patients who are considered at intermediate or high risk for relapse (unfavorable cytogenetics/high WBC) and have a suitable related donor undergo an allogeneic transplantation. Patients with intermediate-risk cytogenetics, WBC no greater than 100,000/mm^3, and appropriate donors have the option of undergoing allogeneic transplantation.
Patients who do not meet the criteria for allogeneic transplantation (i.e., are favorable risk or do not have a matching related donor) or who opt not to undergo allogeneic transplantation proceed to consolidation therapy followed by randomization to 1 of 2 autologous transplantation arms.
Consolidation therapy: Beginning 2-8 weeks after recovery from induction therapy, patients receive high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. A second course is administered 3 weeks after blood recovery. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days and then autologous PBSCs are harvested by leukapheresis.
Autologous stem cell transplantation: Patients are randomized to 1 of 2 autologous transplantation arms.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for up to 7 years.
ACTUAL ACCRUAL: A total of 657 patients were accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Daunorubicin Then Autologous HCT | Experimental | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
|
| High-dose Daunorubicin Then Autologous HCT | Experimental | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sargramostim | Biological | Given IV or as an injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Induction Phase) | Overall survival is defined as the time from randomization in the induction phase to death. | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter. |
| Disease-free Survival (Consolidation Phase) | Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease. | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Consolidation Phase) | Overall survival is defined as the time from randomization in the consolidation phase to death. | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. |
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Inclusion Criteria:
Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the peripheral blood or marrow) meeting any of the following criteria:
Recurrent cytogenetic translocations
t(8;21)(q22;q22)
Bone marrow eosinophil abnormalities
11q23 abnormalities
Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)
Minimally differentiated AML
AML without maturation
AML with maturation
AML not otherwise categorized
Acute myelomonocytic leukemia
Acute monocytic leukemia
Acute erythroid leukemia
Acute megakaryocytic leukemia
Acute basophilic leukemia
Patients undergoing allogeneic transplantation must have a sibling donor match defined as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on other haplotype
Age 16 to 60
Eastern Cooperative Oncology Group (ECOG) performance status 0-4
Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)
Alkaline phosphatase less than 4 times ULN
Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 50 mL/min
Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated acquisition (MUGA) scan
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
Prior hydroxyurea allowed
Prior corticosteroids allowed
Exclusion Criteria:
Recurrent cytogenetic translocations
Multilineage dysplasia with prior MDS
Acute panmyelosis with myelofibrosis
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| Name | Affiliation | Role |
|---|---|---|
| Hugo F. Fernandez, MD | H. Lee Moffitt Cancer Center and Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19776406 | Result | Fernandez HF, Sun Z, Yao X, Litzow MR, Luger SM, Paietta EM, Racevskis J, Dewald GW, Ketterling RP, Bennett JM, Rowe JM, Lazarus HM, Tallman MS. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009 Sep 24;361(13):1249-59. doi: 10.1056/NEJMoa0904544. | |
| Result | Fernandez HF, Sun Z, Bennett JM, et al.: A single dose of gemtuzumab-ozogamicin (GO) in consolidation prior to autologous transplant for younger patients with newly diagnosed acute myeloid (AML) is safe but has no effect on disease free survival: interim results of Eastern Cooperative Oncology Group study (E1900). [Abstract] Biol Blood Marrow Transplant 14 (2): A-52, 21-2, 2008. | ||
| 16996130 |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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From December 19, 2002 through November 2008, a total of 657 patients were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Daunorubicin Then Autologous HCT | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction |
|
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| Standard Daunorubicin Then GO/Autologous HCT | Experimental | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
|
| High-dose Daunorubicin Then GO/Autologous HCT | Experimental | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
|
| Standard Daunorubicin Then Allogeneic HCT or no Consolidation | Active Comparator | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available. |
|
| High-dose Daunorubicin Then Allogeneic HCT or no Consolidation | Experimental | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available. |
|
|
| busulfan | Drug | Given IV |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| cytarabine | Drug | Given as a continuous infusion |
|
|
| gemtuzumab ozogamicin (GO) | Drug | Given IV |
|
|
| Daunorubicin | Drug | Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2. |
|
|
| Autologous HCT | Procedure | Autologous hematopoietic cell transplantation |
|
|
| Allogeneic HCT | Procedure | Allogeneic hematopoietic cell transplantation |
|
|
| Mayo Clinic Scottsdale |
| Scottsdale |
| Arizona |
| 85259-5499 |
| United States |
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | United States |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80502 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | United States |
| North Suburban Medical Center | Thornton | Colorado | 80229 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West | Boca Raton | Florida | 33428 | United States |
| Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton | Florida | 33486 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | United States |
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois | 60201-1781 | United States |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | United States |
| La Grange Oncology Associates - Geneva | Naperville | Illinois | 60563 | United States |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | 60714 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | United States |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46815 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Tufts-NEMC Cancer Center | Boston | Massachusetts | 02111 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Broadway | Fargo | North Dakota | 58122 | United States |
| Mercy Cancer Center at Mercy Medical Center | Canton | Ohio | 44708 | United States |
| Aultman Cancer Center at Aultman Hospital | Canton | Ohio | 44710-1799 | United States |
| Jewish Hospital Cancer Center | Cincinnati | Ohio | 45236 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | United States |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Result |
| Vance GH, Kim H, Hicks GA, Cherry AM, Higgins R, Hulshizer RL, Tallman MS, Fernandez HF, Dewald GW. Utility of interphase FISH to stratify patients into cytogenetic risk categories at diagnosis of AML in an Eastern Cooperative Oncology Group (ECOG) clinical trial (E1900). Leuk Res. 2007 May;31(5):605-9. doi: 10.1016/j.leukres.2006.07.026. Epub 2006 Sep 22. |
| Result | Fernandez HF, Kim HT, Bennett JM, et al.: Gemtuzumab-ozogamicin (GO; mylotarg®) as part of consolidation therapy for AML before autograft: low incidence of hepatic veno-occlusive disease. [Abstract] Biol Blood Marrow Transplant 11 (2 Suppl 1): A-187, 2005. |
| 22855599 | Result | Gonen M, Sun Z, Figueroa ME, Patel JP, Abdel-Wahab O, Racevskis J, Ketterling RP, Fernandez H, Rowe JM, Tallman MS, Melnick A, Levine RL, Paietta E. CD25 expression status improves prognostic risk classification in AML independent of established biomarkers: ECOG phase 3 trial, E1900. Blood. 2012 Sep 13;120(11):2297-306. doi: 10.1182/blood-2012-02-414425. Epub 2012 Aug 1. |
| 21415269 | Result | Fernandez HF, Sun Z, Litzow MR, Luger SM, Paietta EM, Racevskis J, Dewald G, Ketterling RP, Rowe JM, Lazarus HM, Tallman MS. Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. Blood. 2011 May 19;117(20):5306-13. doi: 10.1182/blood-2010-09-309229. Epub 2011 Mar 17. |
| 37267439 | Derived | Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282. |
| 37185873 | Derived | Foran JM, Sun Z, Lai C, Fernandez HF, Cripe LD, Ketterling RP, Racevskis J, Luger SM, Paietta E, Lazarus HM, Zhang Y, Bennett JM, Levine RL, Rowe JM, Litzow MR, Tallman MS. Obesity in adult acute myeloid leukemia is not associated with inferior response or survival even when dose capping anthracyclines: An ECOG-ACRIN analysis. Cancer. 2023 Aug 15;129(16):2479-2490. doi: 10.1002/cncr.34807. Epub 2023 Apr 25. |
| 36332294 | Derived | Ganzel C, Sun Z, Baslan T, Zhang Y, Gonen M, Abdel-Wahab OI, Racevskis J, Garrett-Bakelman F, Lowe SW, Fernandez HF, Ketterling R, Luger SM, Litzow M, Lazarus HM, Rowe JM, Tallman MS, Levine RL, Paietta E. Measurable residual disease by flow cytometry in acute myeloid leukemia is prognostic, independent of genomic profiling. Leuk Res. 2022 Dec;123:106971. doi: 10.1016/j.leukres.2022.106971. Epub 2022 Oct 21. |
| 27446991 | Derived | Luskin MR, Gimotty PA, Smith C, Loren AW, Figueroa ME, Harrison J, Sun Z, Tallman MS, Paietta EM, Litzow MR, Melnick AM, Levine RL, Fernandez HF, Luger SM, Carroll M, Master SR, Wertheim GB. A clinical measure of DNA methylation predicts outcome in de novo acute myeloid leukemia. JCI Insight. 2016 Jun 16;1(9):e87323. doi: 10.1172/jci.insight.87323. |
| 26755712 | Derived | Luskin MR, Lee JW, Fernandez HF, Abdel-Wahab O, Bennett JM, Ketterling RP, Lazarus HM, Levine RL, Litzow MR, Paietta EM, Patel JP, Racevskis J, Rowe JM, Tallman MS, Sun Z, Luger SM. Benefit of high-dose daunorubicin in AML induction extends across cytogenetic and molecular groups. Blood. 2016 Mar 24;127(12):1551-8. doi: 10.1182/blood-2015-07-657403. Epub 2016 Jan 11. |
| 25772026 | Derived | Walter RB, Othus M, Paietta EM, Racevskis J, Fernandez HF, Lee JW, Sun Z, Tallman MS, Patel J, Gonen M, Abdel-Wahab O, Levine RL, Estey EH. Effect of genetic profiling on prediction of therapeutic resistance and survival in adult acute myeloid leukemia. Leukemia. 2015 Oct;29(10):2104-7. doi: 10.1038/leu.2015.76. Epub 2015 Mar 16. No abstract available. |
| FG001 | High-dose Daunorubicin Then Autologous HCT | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
| FG002 | Standard Daunorubicin Then GO/Autologous HCT | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
| FG003 | High-dose Daunorubicin Then GO/Autologous HCT | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days. |
| FG004 | Standard Daunorubicin Then Allogeneic HCT or no Consolidation | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available. |
| FG005 | High-dose Daunorubicin Then Allogeneic HCT or no Consolidation | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Conditioning/Transplant |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Daunorubicin (Induction Therapy) | Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. |
| BG001 | High Dose Daunorubicin (Induction Therapy) | Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Overall Survival (Induction Phase) | Overall survival is defined as the time from randomization in the induction phase to death. | All randomized patients are included in the analysis (intention-to-treat). | Posted | Median | 95% Confidence Interval | months | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter. |
|
|
| ||||||||||||||||||||||||||||
| Primary | Disease-free Survival (Consolidation Phase) | Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease. | Only 270 patients who were randomized in the consolidation phase are included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (Consolidation Phase) | Overall survival is defined as the time from randomization in the consolidation phase to death. | Only 270 patients who were randomized in the consolidation phase are included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. |
|
|
Assessed weekly while on treatment and for 30 days after the end of treatment.
Not provided
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 | Standard Daunorubicin (Induction Therapy) | Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Conditioning/Transplant: Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover. | 328 | 328 | 319 | 328 | ||
| EG001 | High Dose Daunorubicin (Induction Therapy) | Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I. Conditioning/Transplant: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I. | 325 | 325 | 318 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Marrow Cellularity | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Transfusion platelets | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Transfusion: PRBCS | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| VOD | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Supraventricular arrhythmias | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ventricular arrthhmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arrhythmia-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Acute Vascular leak syndrome | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac ischemia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| DIC | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Wound-infectious | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin Increased | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| AST increased | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| ALT Increased | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac-Left Ventricular Function | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac Troponin I | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Operative Injury of Vein/Artery | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Pericardial Effusion/Pericarditis | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constitutional symptoms | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hand-Foot Reaction | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Wound - non-infectious | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Skin- Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SIADH | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea w/ prior colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage with Grade 3 or 4 Platelets | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage without Grade 3 or 4 Platelets | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| CNS hemorrhage | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage Associated with Surgery | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/GI Bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Petechiae | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rectal Bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vaginal Bleeding | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage-Other | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/ Gr3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Catheter-Related Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/o neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection- Other | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Acidosis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Joint, Muscle, Bone-Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depressed Level of consciousness | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/Lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety/Agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Speech Impairment | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ocular-Other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone, pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rectal or Perirectal Pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
Not provided
Not provided
| ID | Term |
|---|---|
| C081222 | sargramostim |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D000079982 | Gemtuzumab |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Adverse Event |
|
| Death |
|
| Withdrawal by Subject |
|
| Alternative therapy |
|
| Other complicating disease |
|
| Reasons not reported |
|
| Male |
|
|
|