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S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00492856
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : July 18, 2014
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: 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
Low and Intermediate Risk APL Patients All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
Post-consolidation ATRA, 6-MP, MTX Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
Post-consolidation Observation Patients who achieved CRm after consolidation and were randomized to the observation arm.
Post-consolidation Gemtuzumab Ozogamicin Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).

Participant Flow for 3 periods

Period 1:   Induction
    Low and Intermediate Risk APL Patients   Post-consolidation ATRA, 6-MP, MTX   Post-consolidation Observation   Post-consolidation Gemtuzumab Ozogamicin
STARTED   105   0   0   0 
COMPLETED   99   0   0   0 
NOT COMPLETED   6   0   0   0 
Adverse Event                2                0                0                0 
Withdrawal by Subject                1                0                0                0 
Death                3                0                0                0 

Period 2:   Consolidation
    Low and Intermediate Risk APL Patients   Post-consolidation ATRA, 6-MP, MTX   Post-consolidation Observation   Post-consolidation Gemtuzumab Ozogamicin
STARTED   92 [1]   0   0   0 
COMPLETED   83   0   0   0 
NOT COMPLETED   9   0   0   0 
Adverse Event                6                0                0                0 
Not protocol specified                2                0                0                0 
Lost to Follow-up                1                0                0                0 
[1] Patients in CR (CRm), CRi, or PR after induction, register for consolidation and are eligible.

Period 3:   Post-consolidation
    Low and Intermediate Risk APL Patients   Post-consolidation ATRA, 6-MP, MTX   Post-consolidation Observation   Post-consolidation Gemtuzumab Ozogamicin
STARTED   0 [1]   41   27   1 
COMPLETED   0   29   0   0 
NOT COMPLETED   0   12   27   1 
Adverse Event                0                4                0                1 
Withdrawal by Subject                0                4                0                0 
Death                0                1                0                0 
Not protocol specified                0                1                0                0 
Lost to Follow-up                0                2                0                0 
Observation Arm                0                0                27                0 
[1] Patients who achieve CRm, are randomized to the treatment arm, and are eligible.



  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.
No text entered.

Reporting Groups
  Description
Low and Intermediate Risk APL Patients All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.

Baseline Measures
   Low and Intermediate Risk APL Patients 
Overall Participants Analyzed 
[Units: Participants]
 105 
Age 
[Units: Years]
Median (Full Range)
 49 
 (21 to 82) 
Gender 
[Units: Participants]
 
Female   44 
Male   61 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   7 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   8 
White   87 
More than one race   0 
Unknown or Not Reported   2 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   6 
Not Hispanic or Latino   87 
Unknown or Not Reported   12 


  Outcome Measures

1.  Primary:   3-year Disease-free Survival (DFS) Rate   [ Time Frame: Up to 3 years ]

2.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ 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 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:  
Name/Title: SWOG Leukemia Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4408


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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00492856     History of Changes
Other Study ID Numbers: S0521
S0521 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2007
First Posted: June 27, 2007
Results First Submitted: April 22, 2014
Results First Posted: July 18, 2014
Last Update Posted: May 17, 2016