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Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049517
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : February 12, 2013
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: sargramostim
Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Drug: gemtuzumab ozogamicin (GO)
Drug: Daunorubicin
Procedure: Autologous HCT
Procedure: Allogeneic HCT
Enrollment 657
Recruitment Details From December 2002 through November 2008, a total of 657 patients were enrolled in the study.
Pre-assignment Details  
Arm/Group Title Standard Daunorubicin Then Autologous HCT High-dose Daunorubicin Then Autologous HCT Standard Daunorubicin Then GO/Autologous HCT High-dose Daunorubicin Then GO/Autologous HCT Standard Daunorubicin Then Allogeneic HCT or no Consolidation High-dose Daunorubicin Then Allogeneic HCT or no Consolidation
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Induction
Started 79 90 63 75 188 162
Treated 79 90 63 75 186 160
Completed 79 90 63 75 128 108
Not Completed 0 0 0 0 60 54
Reason Not Completed
Disease progression             0             0             0             0             18             11
Adverse Event             0             0             0             0             5             7
Death             0             0             0             0             9             6
Withdrawal by Subject             0             0             0             0             1             3
Alternative therapy             0             0             0             0             2             2
Other complicating disease             0             0             0             0             3             0
Reasons not reported             0             0             0             0             22             25
Period Title: Conditioning/Transplant
Started 79 90 63 75 21 24
Randomized to Autologous HCT +/- GO 59 [1] 73 [2] 63 75 0 [3] 0 [4]
Completed 27 40 25 32 15 18
Not Completed 52 50 38 43 6 6
Reason Not Completed
Disease progression             14             6             10             6             0             0
Adverse Event             2             1             4             8             0             0
Death             1             0             0             2             0             0
Withdrawal by Subject             4             8             4             7             0             0
Alternative therapy             4             4             2             1             1             0
Other complicating disease             2             0             0             4             0             1
Reasons not reported             25             31             18             15             5             5
[1]
Additional 20 patients received Autologous HCT without randomization.
[2]
Additional 17 patients received Autologous HCT without randomization.
[3]
These 21 patients received Allogeneic HCT without randomization.
[4]
These 24 patients received Allogeneic HCT without randomization.
Arm/Group Title Standard Daunorubicin (Induction Therapy) High Dose Daunorubicin (Induction Therapy) Total
Hide Arm/Group Description

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 330 327 657
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 330 participants 327 participants 657 participants
47
(17 to 60)
48
(18 to 60)
48
(17 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 327 participants 657 participants
Female
158
  47.9%
164
  50.2%
322
  49.0%
Male
172
  52.1%
163
  49.8%
335
  51.0%
1.Primary Outcome
Title Overall Survival (Induction Phase)
Hide Description Overall survival is defined as the time from randomization in the induction phase to death.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients are included in the analysis (intention-to-treat).
Arm/Group Title Standard Daunorubicin High-dose Daunorubicin
Hide Arm/Group Description:
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. Patients with CR received consolidation treatment thereafter.
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. Patients with CR received consolidation treatment thereafter.
Overall Number of Participants Analyzed 330 327
Median (95% Confidence Interval)
Unit of Measure: months
15.7
(12.7 to 19.0)
23.7
(19.0 to 31.7)
2.Primary Outcome
Title Disease-free Survival (Consolidation Phase)
Hide Description Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Only 270 patients who were randomized in the consolidation phase are included in the analysis.
Arm/Group Title Autologous HCT Go/Autologous HCT
Hide Arm/Group Description:
Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
Overall Number of Participants Analyzed 132 138
Median (95% Confidence Interval)
Unit of Measure: Months
15.0
(11.4 to 23.9)
13.6
(10.7 to 18.4)
3.Secondary Outcome
Title Overall Survival (Consolidation Phase)
Hide Description Overall survival is defined as the time from randomization in the consolidation phase to death.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Only 270 patients who were randomized in the consolidation phase are included in the analysis.
Arm/Group Title Autologous HCT Go/Autologous HCT
Hide Arm/Group Description:
Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
Overall Number of Participants Analyzed 132 138
Median (95% Confidence Interval)
Unit of Measure: Months
35.5
(24.2 to 51.7)
27.9
(20.3 to 39.5)
Time Frame Assessed weekly while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Daunorubicin (Induction Therapy) High Dose Daunorubicin (Induction Therapy)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Standard Daunorubicin (Induction Therapy) High Dose Daunorubicin (Induction Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Daunorubicin (Induction Therapy) High Dose Daunorubicin (Induction Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   328/328 (100.00%)   325/325 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  257/328 (78.35%)  251/325 (77.23%) 
Hemolysis  1  1/328 (0.30%)  0/325 (0.00%) 
Leukopenia  1  320/328 (97.56%)  323/325 (99.38%) 
Lymphopenia  1  3/328 (0.91%)  4/325 (1.23%) 
Neutropenia  1  319/328 (97.26%)  305/325 (93.85%) 
Thrombocytopenia  1  321/328 (97.87%)  321/325 (98.77%) 
Transfusion platelets  1  199/328 (60.67%)  206/325 (63.38%) 
Transfusion: PRBCS  1  197/328 (60.06%)  191/325 (58.77%) 
Hematologic-other  1  1/328 (0.30%)  0/325 (0.00%) 
Hypertension  1  5/328 (1.52%)  2/325 (0.62%) 
Hypotension  1  9/328 (2.74%)  12/325 (3.69%) 
Thrombosis  1  4/328 (1.22%)  2/325 (0.62%) 
Weight gain  1  1/328 (0.30%)  0/325 (0.00%) 
DIC  1  5/328 (1.52%)  2/325 (0.62%) 
Bilirubin Increased  1  13/328 (3.96%)  15/325 (4.62%) 
Hypoalbuminemia  1  5/328 (1.52%)  3/325 (0.92%) 
AST increased  1  3/328 (0.91%)  4/325 (1.23%) 
ALT Increased  1  10/328 (3.05%)  5/325 (1.54%) 
Febrile neutropenia  1  121/328 (36.89%)  117/325 (36.00%) 
Hypokalemia  1  0/328 (0.00%)  1/325 (0.31%) 
CNS hemorrhage  1  2/328 (0.61%)  1/325 (0.31%) 
Petechiae  1  5/328 (1.52%)  2/325 (0.62%) 
Cardiac disorders     
Sinus Tachycardia  1  0/328 (0.00%)  2/325 (0.62%) 
Supraventricular arrhythmias  1  1/328 (0.30%)  6/325 (1.85%) 
Ventricular arrthhmia  1  1/328 (0.30%)  2/325 (0.62%) 
Arrhythmia-other  1  0/328 (0.00%)  1/325 (0.31%) 
Acute Vascular leak syndrome  1  0/328 (0.00%)  1/325 (0.31%) 
Cardiac ischemia  1  0/328 (0.00%)  1/325 (0.31%) 
Cardiac-Left Ventricular Function  1  0/328 (0.00%)  4/325 (1.23%) 
Cardiac Troponin I  1  1/328 (0.30%)  0/325 (0.00%) 
Pericardial Effusion/Pericarditis  1  2/328 (0.61%)  0/325 (0.00%) 
Cardiac-other  1  1/328 (0.30%)  2/325 (0.62%) 
Ear and labyrinth disorders     
Stomatitis  1  9/328 (2.74%)  20/325 (6.15%) 
Gastrointestinal disorders     
Colitis  1  6/328 (1.83%)  8/325 (2.46%) 
Diarrhea  1  2/328 (0.61%)  1/325 (0.31%) 
Dysphagia  1  2/328 (0.61%)  4/325 (1.23%) 
Nausea  1  19/328 (5.79%)  16/325 (4.92%) 
Typhlitis  1  6/328 (1.83%)  9/325 (2.77%) 
Vomiting  1  7/328 (2.13%)  8/325 (2.46%) 
Constipation  1  0/328 (0.00%)  1/325 (0.31%) 
Ileus  1  0/328 (0.00%)  3/325 (0.92%) 
Proctitis  1  4/328 (1.22%)  0/325 (0.00%) 
Diarrhea w/o prior colostomy  1  7/328 (2.13%)  12/325 (3.69%) 
Diarrhea w/ prior colostomy  1  1/328 (0.30%)  1/325 (0.31%) 
GI-other  1  1/328 (0.30%)  3/325 (0.92%) 
Hematemesis  1  1/328 (0.30%)  0/325 (0.00%) 
Melena/GI Bleeding  1  0/328 (0.00%)  4/325 (1.23%) 
Rectal Bleeding  1  1/328 (0.30%)  1/325 (0.31%) 
Abdominal Pain  1  4/328 (1.22%)  3/325 (0.92%) 
Rectal or Perirectal Pain  1  2/328 (0.61%)  2/325 (0.62%) 
General disorders     
VOD  1  1/328 (0.30%)  1/325 (0.31%) 
Edema  1  1/328 (0.30%)  0/325 (0.00%) 
Fatigue  1  18/328 (5.49%)  19/325 (5.85%) 
Fever  1  22/328 (6.71%)  29/325 (8.92%) 
Weight loss  1  1/328 (0.30%)  3/325 (0.92%) 
Epistaxis  1  8/328 (2.44%)  10/325 (3.08%) 
Dyspnea  1  18/328 (5.49%)  13/325 (4.00%) 
Rigors/chills  1  0/328 (0.00%)  1/325 (0.31%) 
Constitutional symptoms  1  1/328 (0.30%)  0/325 (0.00%) 
Chest Pain  1  1/328 (0.30%)  0/325 (0.00%) 
Pain-other  1  5/328 (1.52%)  4/325 (1.23%) 
Infections and infestations     
Wound-infectious  1  2/328 (0.61%)  1/325 (0.31%) 
Infection w/ Gr3-4 neutropenia  1  154/328 (46.95%)  168/325 (51.69%) 
Catheter-Related Infection  1  1/328 (0.30%)  4/325 (1.23%) 
Infection w/ unknown ANC  1  1/328 (0.30%)  1/325 (0.31%) 
Infection w/o neutropenia  1  10/328 (3.05%)  13/325 (4.00%) 
Infection- Other  1  1/328 (0.30%)  1/325 (0.31%) 
Acidosis  1  0/328 (0.00%)  1/325 (0.31%) 
Injury, poisoning and procedural complications     
Operative Injury of Vein/Artery  1  1/328 (0.30%)  0/325 (0.00%) 
Wound - non-infectious  1  0/328 (0.00%)  1/325 (0.31%) 
Hemorrhage with Grade 3 or 4 Platelets  1  30/328 (9.15%)  36/325 (11.08%) 
Hemorrhage without Grade 3 or 4 Platelets  1  0/328 (0.00%)  1/325 (0.31%) 
Hemorrhage Associated with Surgery  1  1/328 (0.30%)  1/325 (0.31%) 
Investigations     
PTT  1  1/328 (0.30%)  0/325 (0.00%) 
SIADH  1  1/328 (0.30%)  0/325 (0.00%) 
Alkaline phosphatase increased  1  1/328 (0.30%)  6/325 (1.85%) 
Creatinine increased  1  2/328 (0.61%)  1/325 (0.31%) 
Metabolism and nutrition disorders     
hyperglycemia  1  7/328 (2.13%)  4/325 (1.23%) 
Dehydration  1  0/328 (0.00%)  1/325 (0.31%) 
Hypernatremia  1  0/328 (0.00%)  1/325 (0.31%) 
Hypocalcemia  1  4/328 (1.22%)  3/325 (0.92%) 
Hypokalemia  1  11/328 (3.35%)  9/325 (2.77%) 
Hyponatremia  1  6/328 (1.83%)  8/325 (2.46%) 
Hypophosphatemia  1  3/328 (0.91%)  4/325 (1.23%) 
Tumor Lysis Syndrome  1  2/328 (0.61%)  2/325 (0.62%) 
Musculoskeletal and connective tissue disorders     
Bone Marrow Cellularity  1  0/328 (0.00%)  1/325 (0.31%) 
Arthritis  1  1/328 (0.30%)  0/325 (0.00%) 
Muscle Weakness  1  1/328 (0.30%)  0/325 (0.00%) 
Myositis  1  0/328 (0.00%)  1/325 (0.31%) 
Joint, Muscle, Bone-Other  1  1/328 (0.30%)  0/325 (0.00%) 
Arthralgia  1  2/328 (0.61%)  3/325 (0.92%) 
Bone, pain  1  2/328 (0.61%)  2/325 (0.62%) 
Myalgia  1  1/328 (0.30%)  3/325 (0.92%) 
Nervous system disorders     
Ataxia  1  0/328 (0.00%)  1/325 (0.31%) 
Dizziness/Lightheadedness  1  4/328 (1.22%)  0/325 (0.00%) 
Neuropathy-motor  1  1/328 (0.30%)  0/325 (0.00%) 
Neuropathy-sensory  1  0/328 (0.00%)  1/325 (0.31%) 
Seizure  1  1/328 (0.30%)  1/325 (0.31%) 
Speech Impairment  1  1/328 (0.30%)  0/325 (0.00%) 
Syncope  1  6/328 (1.83%)  0/325 (0.00%) 
Ocular-Other  1  2/328 (0.61%)  0/325 (0.00%) 
Headache  1  4/328 (1.22%)  4/325 (1.23%) 
Psychiatric disorders     
Anorexia  1  26/328 (7.93%)  32/325 (9.85%) 
Confusion  1  3/328 (0.91%)  5/325 (1.54%) 
Depressed Level of consciousness  1  0/328 (0.00%)  2/325 (0.62%) 
Hallucinations  1  2/328 (0.61%)  0/325 (0.00%) 
Insomnia  1  1/328 (0.30%)  0/325 (0.00%) 
Anxiety/Agitation  1  2/328 (0.61%)  2/325 (0.62%) 
Depression  1  0/328 (0.00%)  2/325 (0.62%) 
Renal and urinary disorders     
Hematuria  1  1/328 (0.30%)  2/325 (0.62%) 
Renal Failure  1  3/328 (0.91%)  3/325 (0.92%) 
Reproductive system and breast disorders     
Vaginal Bleeding  1  3/328 (0.91%)  1/325 (0.31%) 
Respiratory, thoracic and mediastinal disorders     
Hemoptysis  1  2/328 (0.61%)  3/325 (0.92%) 
Pleuritic Pain  1  0/328 (0.00%)  2/325 (0.62%) 
ARDS  1  3/328 (0.91%)  1/325 (0.31%) 
Cough  1  1/328 (0.30%)  0/325 (0.00%) 
Dyspnea  1  18/328 (5.49%)  13/325 (4.00%) 
Hypoxia  1  12/328 (3.66%)  14/325 (4.31%) 
Pleural effusion  1  2/328 (0.61%)  4/325 (1.23%) 
Pneumonitis/pulmonary infiltrates  1  7/328 (2.13%)  11/325 (3.38%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  2/328 (0.61%)  2/325 (0.62%) 
Rash  1  17/328 (5.18%)  16/325 (4.92%) 
Hand-Foot Reaction  1  1/328 (0.30%)  0/325 (0.00%) 
Skin- Other  1  1/328 (0.30%)  0/325 (0.00%) 
Vascular disorders     
Hot flashes  1  0/328 (0.00%)  1/325 (0.31%) 
Hemorrhage-Other  1  1/328 (0.30%)  1/325 (0.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Daunorubicin (Induction Therapy) High Dose Daunorubicin (Induction Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   319/328 (97.26%)   318/325 (97.85%) 
Blood and lymphatic system disorders     
Anemia  1  319/328 (97.26%)  318/325 (97.85%) 
Leukopenia  1  281/328 (85.67%)  267/325 (82.15%) 
Neutropenia  1  243/328 (74.09%)  230/325 (70.77%) 
Thrombocytopenia  1  295/328 (89.94%)  292/325 (89.85%) 
General disorders     
Nausea  1  16/328 (4.88%)  18/325 (5.54%) 
Fatigue  1  11/328 (3.35%)  18/325 (5.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Publications of Results:
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.
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.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00049517     History of Changes
Other Study ID Numbers: CDR0000258113
U10CA021115 ( U.S. NIH Grant/Contract )
E1900 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: November 12, 2002
First Posted: January 27, 2003
Results First Submitted: January 10, 2013
Results First Posted: February 12, 2013
Last Update Posted: January 14, 2019