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Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00742625
First received: August 27, 2008
Last updated: September 4, 2014
Last verified: June 2014
Results First Received: January 2, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: bortezomib

  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
Between September 2008 and February 2010, 98 participants were recruited at 15 CALGB member institutions and their affiliated hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three (3) participants did not begin treatment and were excluded from all analyses per study design

Reporting Groups
  Description
Bortezomib + Daunorubicin + Cytarabine

Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)


Participant Flow for 2 periods

Period 1:   Remission Induction
    Bortezomib + Daunorubicin + Cytarabine  
STARTED     95  
COMPLETED     41  
NOT COMPLETED     54  
Progression                 6  
Failed induction                 8  
Adverse Event                 3  
Death                 10  
Refusal                 5  
Non protocol treatment                 17  
Other, not specified                 5  

Period 2:   Consolidation
    Bortezomib + Daunorubicin + Cytarabine  
STARTED     41  
COMPLETED     20  
NOT COMPLETED     21  
Progression                 5  
Adverse Event                 1  
Death                 1  
Refused                 1  
Non protocol therapy                 13  



  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
Bortezomib + Daunorubicin + Cytarabine

Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)


Baseline Measures
    Bortezomib + Daunorubicin + Cytarabine  
Number of Participants  
[units: participants]
  95  
Age  
[units: years]
Median ( Full Range )
  67  
  ( 60 to 75 )  
Gender  
[units: participants]
 
Female     42  
Male     53  
Region of Enrollment  
[units: participants]
 
United States     95  
ECOG Performance Status [1]
[units: participants]
 
0 - Fully Active     31  
1 - Ambulatory, restricted strenuous activity     55  
2 - Ambulatory, unable to perform work activities     9  
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Remission Induction Response   [ Time Frame: 2 months ]

2.  Primary:   Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine   [ Time Frame: during consolidation cycle 1 (42 days) ]

3.  Secondary:   Disease-free Survival   [ Time Frame: Duration of study (up to 10 years) ]

4.  Secondary:   Overall Survival   [ Time Frame: Duration of study (up to 10 years) ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information
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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: Eyal Attar, MD
Organization: Massachusetts General Hospital Cancer Center
phone: 617-724-1124
e-mail: eattar@partners.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00742625     History of Changes
Obsolete Identifiers: NCT01647061
Other Study ID Numbers: NCI-2009-00443, NCI-2009-00443, CDR0000612758, CALGB 10502, CALGB-10502, U10CA031946, P30CA014236
Study First Received: August 27, 2008
Results First Received: January 2, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration