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Trial record 15 of 188 for:    "Acute erythroleukemia" "Acute erythroid leukemia"

Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01870596
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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 Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Recurrent Adult Acute Myeloid Leukemia
Interventions: Drug: Cytarabine
Drug: CHK1 Inhibitor SCH 900776
Other: Laboratory Biomarker Analysis

  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
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)

Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.

Cytarabine: Given IV

CHK1 Inhibitor SCH 900776: Given IV

Laboratory Biomarker Analysis: Correlative studies

Arm B (Cytarabine)

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)   Arm B (Cytarabine)
STARTED   14   18 
COMPLETED   14   18 
NOT COMPLETED   0   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
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)

Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.

Cytarabine: Given IV

CHK1 Inhibitor SCH 900776: Given IV

Laboratory Biomarker Analysis: Correlative studies

Arm B (Cytarabine)

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)   Arm B (Cytarabine)   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   18   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   12   23 
>=65 years   3   6   9 
Age 
[Units: Years]
Median (Full Range)
 60 
 (29 to 72) 
 60 
 (29 to 72) 
 60 
 (29 to 72) 
Gender 
[Units: Participants]
     
Female   6   9   15 
Male   8   9   17 
Region of Enrollment 
[Units: Participants]
     
United States   14   18   32 


  Outcome Measures

1.  Primary:   Response Rate(CR/CRi) Rate   [ 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 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: B. Douglas Smith
Organization: Sidney Kimmel Comprehensive Cancer Center
phone: (410) 287-2935
e-mail: bdsmith@JHMI.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01870596     History of Changes
Other Study ID Numbers: NCI-2013-01097
NCI-2013-01097 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
J1319 ( Other Identifier: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital )
9362 ( Other Identifier: CTEP )
U01CA070095 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: June 3, 2013
First Posted: June 6, 2013
Results First Submitted: September 11, 2015
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016