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S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic 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: NCT00551460
Recruitment Status : Completed
First Posted : October 31, 2007
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: arsenic trioxide
Drug: gemtuzumab ozogamicin
Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin

  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
ATRA + GO + Arsenic

Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR

Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest

Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3

Consolidation 5 and 6: GO 9mg/m2 IV D1

Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year


Participant Flow:   Overall Study
    ATRA + GO + Arsenic
STARTED   78 
COMPLETED   60 
NOT COMPLETED   18 
Adverse Event                1 
Withdrawal by Subject                1 
Physician Decision                1 
Death                7 
Ineligible                4 
Not analyzable (did not start treatment)                4 



  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.
Baseline Participants includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.

Reporting Groups
  Description
ATRA + GO + Arsenic Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year

Baseline Measures
   ATRA + GO + Arsenic 
Overall Participants Analyzed 
[Units: Participants]
 70 
Age 
[Units: Years]
Median (Full Range)
 46.5 
 (19.2 to 86.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      37  52.9% 
Male      33  47.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   1.4% 
Native Hawaiian or Other Pacific Islander      1   1.4% 
Black or African American      7  10.0% 
White      58  82.9% 
More than one race      0   0.0% 
Unknown or Not Reported      3   4.3% 


  Outcome Measures

1.  Primary:   Continuous Complete Remission at 3 Years   [ Time Frame: 3 years ]

2.  Primary:   Mortality Rate at 6 Weeks   [ Time Frame: 6 weeks ]

3.  Secondary:   Frequency of Toxicities   [ Time Frame: Up to 3 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 less than or equal to 60 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: Leukemia Committee Statistician
Organization: SWOG Statistics and Data Management Center
phone: 2066674623
e-mail: amoseley@fredhutch.org



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00551460     History of Changes
Other Study ID Numbers: S0535
S0535 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2007
First Posted: October 31, 2007
Results First Submitted: November 21, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017