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Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00136084
First received: August 24, 2005
Last updated: November 2, 2012
Last verified: November 2012
Results First Received: March 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia, Myelocytic, Acute
Interventions: Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
Drug: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
238 patients were recruited between October, 2002 and June, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.

Reporting Groups
  Description
Arm 1: (HDAC) High-dose Cytarabine (HDAC)
Arm 2:(LDAC) Low-dose Cytarabine (LDAC)

Participant Flow:   Overall Study
    Arm 1: (HDAC)   Arm 2:(LDAC)
STARTED   109   114 
COMPLETED   61   72 
NOT COMPLETED   48   42 
Death                12                5 
Unacceptable toxicity                8                11 
Relapse                20                23 
Lost to Follow-up                2                0 
No Response                1                2 
Withdrawal by Subject                5                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: (HDAC) High-dose Cytarabine (HDAC)
Arm 2:(LDAC) Low-dose Cytarabine (LDAC)
Total Total of all reporting groups

Baseline Measures
   Arm 1: (HDAC)   Arm 2:(LDAC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 109   114   223 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.57  (6.08)   8.48  (6.32)   8.49  (6.19) 
Gender 
[Units: Participants]
     
Female   50   48   98 
Male   59   66   125 


  Outcome Measures
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1.  Primary:   Minimal Residual Disease (MRD).   [ Time Frame: Day 22 MRD measurement ]

2.  Secondary:   Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)   [ Time Frame: Consolidation I ]

3.  Secondary:   Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO   [ Time Frame: Induction II ]

4.  Secondary:   Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.   [ Time Frame: Induction II ]

5.  Secondary:   To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy   [ Time Frame: Five Year ]

6.  Secondary:   To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy   [ Time Frame: Measurements were assessed in Induction I chemotherapy ]

7.  Secondary:   Relationship of Inhibition of DNA Synthesis and Clinical Response   [ Time Frame: Measurements were assessed in Induction I chemotherapy ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse events have been collected from study inception (October, 2002) through February, 2009.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Arm 1: (HDAC) High-dose Cytarabine (HDAC)
Arm 2:(LDAC) Low-dose Cytarabine (LDAC)

Other Adverse Events
    Arm 1: (HDAC)   Arm 2:(LDAC)
Total, other (not including serious) adverse events     
# participants affected / at risk   107/109 (98.17%)   112/114 (98.25%) 
Blood and lymphatic system disorders     
DIC (disseminated intravascular coagulation) * 1     
# participants affected / at risk   6/109 (5.50%)   0/114 (0.00%) 
# events   6   0 
Epistaxis * 1     
# participants affected / at risk   7/109 (6.42%)   9/114 (7.89%) 
# events   9   14 
Hemorrhage-Other * 1     
# participants affected / at risk   0/109 (0.00%)   12/114 (10.53%) 
# events   0   14 
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia * 1     
# participants affected / at risk   0/109 (0.00%)   6/114 (5.26%) 
# events   0   6 
Cardiac disorders     
Hypertension * 1     
# participants affected / at risk   8/109 (7.34%)   7/114 (6.14%) 
# events   9   9 
Hypotension * 1     
# participants affected / at risk   11/109 (10.09%)   20/114 (17.54%) 
# events   14   21 
Eye disorders     
Conjunctivitis * 1     
# participants affected / at risk   7/109 (6.42%)   0/114 (0.00%) 
# events   7   0 
Gastrointestinal disorders     
Anorexia * 1     
# participants affected / at risk   23/109 (21.10%)   16/114 (14.04%) 
# events   28   26 
Colitis * 1     
# participants affected / at risk   6/109 (5.50%)   0/114 (0.00%) 
# events   7   0 
Dehydration * 1     
# participants affected / at risk   0/109 (0.00%)   6/114 (5.26%) 
# events   0   6 
Diarrhea patients without colostomy * 1     
# participants affected / at risk   21/109 (19.27%)   20/114 (17.54%) 
# events   26   27 
Gastrointestinal-Other * 1     
# participants affected / at risk   8/109 (7.34%)   0/114 (0.00%) 
# events   8   0 
Nausea * 1     
# participants affected / at risk   6/109 (5.50%)   8/114 (7.02%) 
# events   6   11 
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1     
# participants affected / at risk   15/109 (13.76%)   19/114 (16.67%) 
# events   18   22 
Typhlitis (inflammation of cecum) * 1     
# participants affected / at risk   8/109 (7.34%)   16/114 (14.04%) 
# events   10   17 
Vomiting * 1     
# participants affected / at risk   14/109 (12.84%)   15/114 (13.16%) 
# events   15   20 
General disorders     
Abdominal pain or cramping * 1     
# participants affected / at risk   11/109 (10.09%)   0/114 (0.00%) 
# events   12   0 
Headache * 1     
# participants affected / at risk   6/109 (5.50%)   9/114 (7.89%) 
# events   7   11 
Pain-Other * 1     
# participants affected / at risk   6/109 (5.50%)   0/114 (0.00%) 
# events   6   0 
Hepatobiliary disorders     
Bilirubin * 1     
# participants affected / at risk   7/109 (6.42%)   0/114 (0.00%) 
# events   8   0 
GGT (Gamma-Glutamyl transpeptidase) * 1     
# participants affected / at risk   14/109 (12.84%)   8/114 (7.02%) 
# events   21   9 
SGOT (AST) (serum glutamic oxaloacetic transaminase) * 1     
# participants affected / at risk   10/109 (9.17%)   0/114 (0.00%) 
# events   10   0 
SGPT (ALT) (serum glutamic pyruvic transaminase) * 1     
# participants affected / at risk   18/109 (16.51%)   8/114 (7.02%) 
# events   21   9 
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever) * 1     
# participants affected / at risk   17/109 (15.60%)   16/114 (14.04%) 
# events   19   19 
Infections and infestations     
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1     
# participants affected / at risk   69/109 (63.30%)   92/114 (80.70%) 
# events   138   181 
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1     
# participants affected / at risk   0/109 (0.00%)   8/114 (7.02%) 
# events   0   9 
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e * 1     
# participants affected / at risk   83/109 (76.15%)   82/114 (71.93%) 
# events   193   178 
Infection without neutropenia * 1     
# participants affected / at risk   10/109 (9.17%)   13/114 (11.40%) 
# events   10   15 
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory) * 1     
# participants affected / at risk   6/109 (5.50%)   0/114 (0.00%) 
# events   8   0 
Hyperglycemia * 1     
# participants affected / at risk   15/109 (13.76%)   10/114 (8.77%) 
# events   21   13 
Hyperkalemia * 1     
# participants affected / at risk   7/109 (6.42%)   6/114 (5.26%) 
# events   8   14 
Hypocalcemia * 1     
# participants affected / at risk   12/109 (11.01%)   12/114 (10.53%) 
# events   13   17 
Hypokalemia * 1     
# participants affected / at risk   37/109 (33.94%)   38/114 (33.33%) 
# events   79   84 
Hypomagnesmia * 1     
# participants affected / at risk   8/109 (7.34%)   7/114 (6.14%) 
# events   9   11 
Hyponatremia * 1     
# participants affected / at risk   6/109 (5.50%)   9/114 (7.89%) 
# events   8   11 
Hypophosphatemia * 1     
# participants affected / at risk   12/109 (11.01%)   12/114 (10.53%) 
# events   14   14 
Lipase * 1     
# participants affected / at risk   6/109 (5.50%)   0/114 (0.00%) 
# events   7   0 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1     
# participants affected / at risk   19/109 (17.43%)   17/114 (14.91%) 
# events   20   19 
Pleural effusion (non-malignant) * 1     
# participants affected / at risk   0/109 (0.00%)   7/114 (6.14%) 
# events   0   7 
Pneumonitis/pulmonary infiltrates * 1     
# participants affected / at risk   10/109 (9.17%)   0/114 (0.00%) 
# events   12   0 
Skin and subcutaneous tissue disorders     
Rash/desquamation * 1     
# participants affected / at risk   0/109 (0.00%)   8/114 (7.02%) 
# events   0   9 
Wound-infectious * 1     
# participants affected / at risk   0/109 (0.00%)   11/114 (9.65%) 
# events   0   12 
Wound-non-infectious * 1     
# participants affected / at risk   9/109 (8.26%)   6/114 (5.26%) 
# events   10   6 
* Events were collected by non-systematic assessment
1 Term from vocabulary, CTCAE (2.0)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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