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Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00658814
Recruitment Status : Active, not recruiting
First Posted : April 15, 2008
Results First Posted : January 6, 2014
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Azacitidine
Drug: Gemtuzumab Ozogamicin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin

Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.

Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)

Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.

Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.

Patients in continued remission may go on to receive maintenance therapy.

Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)

Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin

Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.

Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)

Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.

Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.

Patients in continued remission may go on to receive maintenance therapy.

Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)


Participant Flow for 3 periods

Period 1:   Remission Induction Chemotherapy
    Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin   Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
STARTED   83   59 
Eligible   82   57 
Eligible and Began Protocol Therapy   79   54 
COMPLETED   75   41 
NOT COMPLETED   8   18 
Adverse Event                1                3 
Withdrawal by Subject                3                4 
Progression/Relapse                0                1 
Death                1                4 
Not protocol specified                2                4 
Not eligible                1                2 

Period 2:   Consolidation Therapy
    Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin   Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
STARTED   24   13 
Eligible   22   11 
COMPLETED   22   10 
NOT COMPLETED   2   3 
Not protocol specified                0                1 
Not eligible                2                2 

Period 3:   Maintenance Therapy
    Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin   Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
STARTED   20   8 
Eligible   19   8 
COMPLETED   17   7 
NOT COMPLETED   3   1 
Adverse Event                1                1 
Not protocol specified                1                0 
Not eligible                1                0 



  Baseline Characteristics

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.
Eligible patients who began protocol therapy

Reporting Groups
  Description
Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin

Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.

Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)

Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.

Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)

Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin

Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.

Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)

Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.

Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)

Total Total of all reporting groups

Baseline Measures
   Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin   Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   54   133 
Age 
[Units: Years]
Median (Full Range)
 71.2 
 (60.5 to 88.7) 
 76 
 (70.3 to 87) 
 73.4 
 (60.5 to 88.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      30  38.0%      21  38.9%      51  38.3% 
Male      49  62.0%      33  61.1%      82  61.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   0   1 
Black or African American   1   4   5 
White   77   50   127 
Hispanic 
[Units: Participants]
     
Yes   3   1   4 
No   64   50   114 
Unknown   12   3   15 


  Outcome Measures

1.  Primary:   Complete Response   [ Time Frame: Up to 60 days ]

2.  Primary:   30-Day Survival   [ Time Frame: 30 days ]

3.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 5 years ]

4.  Secondary:   Relapse-free Survival   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG
phone: 206-667-4623


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00658814     History of Changes
Other Study ID Numbers: NCI-2009-00790
NCI-2009-00790 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000593117
SWOG-S0703
S0703 ( Other Identifier: SWOG )
S0703 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: April 12, 2008
First Posted: April 15, 2008
Results First Submitted: July 22, 2013
Results First Posted: January 6, 2014
Last Update Posted: September 13, 2018