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Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

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ClinicalTrials.gov Identifier: NCT00895934
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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)
Recurrent Adult Acute Myeloid Leukemia
Interventions: Drug: vorinostat
Drug: gemtuzumab ozogamicin
Drug: azacitidine

  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
Phase 1 Dose-Finding Cohorts 1-3

Patients receive vorinostat orally on days 1-9, azacitidine subcutaneously (SC) or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given orally

gemtuzumab ozogamicin: Given IV

azacitidine: Given IV or SC

laboratory biomarker analysis: Correlative studies

Phase 2/Selected Dose Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.

Participant Flow:   Overall Study
    Phase 1 Dose-Finding Cohorts 1-3   Phase 2/Selected Dose
STARTED   10   43 
COMPLETED   4   18 
NOT COMPLETED   6   25 
Lack of Efficacy                5                24 
Death                0                1 
ineligible                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.
No text entered.

Reporting Groups
  Description
Phase 1 Dose-Finding Cohorts 1-3

Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given orally

gemtuzumab ozogamicin: Given IV

azacitidine: Given IV or SC

laboratory biomarker analysis: Correlative studies

Phase 2/Selected Dose Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Phase 1 Dose-Finding Cohorts 1-3   Phase 2/Selected Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   43   53 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   5   21   26 
>=65 years   5   22   27 
Gender 
[Units: Participants]
     
Female   5   18   23 
Male   5   25   30 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   0   6   6 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   9   34   43 
More than one race   0   0   0 
Unknown or Not Reported   0   2   2 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   1   4 
Not Hispanic or Latino   7   40   47 
Unknown or Not Reported   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   10   43   53 


  Outcome Measures

1.  Primary:   Efficacy Defined as Best Response Achieved During Study Treatment Measured by Complete Remission (CR) Rate   [ Time Frame: Up to 3 years ]

2.  Primary:   Dose-limiting Toxicity and Maximum Tolerated Dose of Vorinostat (Phase I)   [ Time Frame: 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Relapse-free Survival (RFS)   [ Time Frame: Up to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Roland B. Walter, MD, PhD
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-3599
e-mail: rwalter@fhcrc.org


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00895934     History of Changes
Other Study ID Numbers: NCI-2012-01147
NCI-2012-01147 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IR-6921 ( Other Identifier: Fred Hutchinson Cancer Research Center )
CDR0000642213 ( Other Identifier: FDA Center for Drug Research )
2288.00 ( Other Identifier: Fred Hutchinson Cancer Research Center )
8297 ( Other Identifier: CTEP )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: August 6, 2014
Results First Posted: February 6, 2015
Last Update Posted: February 6, 2015