ClinicalTrials.gov
ClinicalTrials.gov Menu

Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid 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: 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
Enrollment 32

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Hide Arm/Group Description

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

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 14 18
Completed 14 18
Not Completed 0 0
Arm/Group Title Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine) Total
Hide Arm/Group Description

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

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 14 18 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 18 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  78.6%
12
  66.7%
23
  71.9%
>=65 years
3
  21.4%
6
  33.3%
9
  28.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants 18 participants 32 participants
60
(29 to 72)
60
(29 to 72)
60
(29 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 18 participants 32 participants
Female
6
  42.9%
9
  50.0%
15
  46.9%
Male
8
  57.1%
9
  50.0%
17
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 18 participants 32 participants
14 18 32
1.Primary Outcome
Title Response Rate(CR/CRi) Rate
Hide Description For descriptive purposes, the CR/CRi (complete response/Complete response with incomplete blood count recovery) rate will be reported at the end of the study separately for Arm A and Arm B. Responses are following definitions consistent with those published by Dohner H, Estey EH, Amadori S, et al. CR is defined as Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blasts in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. CRi: All CR criteria except for residual neutropenia (ANC < 1000/μL)
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Hide Arm/Group Description:

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

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 14 18
Measure Type: Number
Unit of Measure: participants
6 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Hide Arm/Group Description

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

Patients receive cytarabine as in Arm A.

Cytarabine: Given IV

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      6/18 (33.33%)    
Cardiac disorders     
Cardiac arrhythmia   0/14 (0.00%)  0 2/18 (11.11%)  2
General disorders     
death multi system organ failure   0/14 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations     
Sepsis   1/14 (7.14%)  1 2/18 (11.11%)  2
Renal and urinary disorders     
Acute Kidney Injusry   1/14 (7.14%)  1 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776) Arm B (Cytarabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      18/18 (100.00%)    
Blood and lymphatic system disorders     
Febrile Neutropenia   5/14 (35.71%)  5 7/18 (38.89%)  7
Hemolysis *  0/14 (0.00%)  0 1/18 (5.56%)  1
Cardiac disorders     
Atrial Fibrillation   1/14 (7.14%)  1 1/18 (5.56%)  1
Sinus Tachycardia   1/14 (7.14%)  1 0/18 (0.00%)  0
Gastrointestinal disorders     
abdominal pain   1/14 (7.14%)  1 0/18 (0.00%)  0
Constipation   1/14 (7.14%)  1 1/18 (5.56%)  1
Colonic hemorrhage   0/14 (0.00%)  0 1/18 (5.56%)  1
diarrhea   1/14 (7.14%)  1 0/18 (0.00%)  0
Dyspepsia   1/14 (7.14%)  1 0/18 (0.00%)  0
Dry mouth   0/14 (0.00%)  0 1/18 (5.56%)  1
Gastroesophageal reflux disease   2/14 (14.29%)  2 2/18 (11.11%)  2
Hemorrhoids   0/14 (0.00%)  0 1/18 (5.56%)  1
Mucositis ora   5/14 (35.71%)  5 2/18 (11.11%)  2
Nausea   3/14 (21.43%)  3 2/18 (11.11%)  2
General disorders     
edema limbs   0/14 (0.00%)  0 1/18 (5.56%)  1
Fatigue   3/14 (21.43%)  3 1/18 (5.56%)  1
fever   1/14 (7.14%)  1 2/18 (11.11%)  2
Infusion related reaction  2/14 (14.29%)  2 1/18 (5.56%)  1
Infections and infestations     
Lung infection   0/14 (0.00%)  0 1/18 (5.56%)  1
Phlebitis infective   0/14 (0.00%)  0 1/18 (5.56%)  1
Sepsis   1/14 (7.14%)  1 1/18 (5.56%)  1
Sinusitis   0/14 (0.00%)  0 1/18 (5.56%)  1
Skin Infection   1/14 (7.14%)  1 0/18 (0.00%)  0
Tooth infection   1/14 (7.14%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications     
Aspartate aminotransferase increased *  0/14 (0.00%)  0 2/18 (11.11%)  2
Bruising   0/14 (0.00%)  0 1/18 (5.56%)  1
Investigations     
Alanine aminotransferase increased *  1/14 (7.14%)  1 3/18 (16.67%)  3
ADVERSE_EVENTS 9362 9362-GA079-129 1 Investigations Alkaline phosphatase increased *  1/14 (7.14%)  1 1/18 (5.56%)  1
Aspartate aminotransferase increased *  1/14 (7.14%)  1 0/18 (0.00%)  0
Blood bilirubin increased *  1/14 (7.14%)  1 0/18 (0.00%)  0
Creatinine increased *  0/14 (0.00%)  0 1/18 (5.56%)  1
Electrocardiogram QT corrected interval prolonged *  4/14 (28.57%)  4 0/18 (0.00%)  0
INR increased *  1/14 (7.14%)  1 0/18 (0.00%)  0
Metabolism and nutrition disorders     
anorexia   1/14 (7.14%)  1 0/18 (0.00%)  0
Hyperglycemia *  4/14 (28.57%)  4 1/18 (5.56%)  1
Hypermagnesemia *  1/14 (7.14%)  1 0/18 (0.00%)  0
Hypoalbuminemia *  1/14 (7.14%)  1 0/18 (0.00%)  0
Hypocalcemia *  1/14 (7.14%)  1 5/18 (27.78%)  5
Hypokalemia *  0/14 (0.00%)  0 3/18 (16.67%)  3
Hyponatremia *  1/14 (7.14%)  1 0/18 (0.00%)  0
Hypomagnesemia *  0/14 (0.00%)  0 1/18 (5.56%)  1
Hypophosphatemia *  0/14 (0.00%)  0 1/18 (5.56%)  1
Tumor Lysis Syndrome   0/14 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders     
back pain   1/14 (7.14%)  1 0/18 (0.00%)  0
Generalized muscle weakness   1/14 (7.14%)  1 1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain   1/14 (7.14%)  1 0/18 (0.00%)  0
Nervous system disorders     
Dysgeusia   0/14 (0.00%)  0 1/18 (5.56%)  1
Headache   0/14 (0.00%)  0 1/18 (5.56%)  1
Peripheral sensory neuropathy   1/14 (7.14%)  1 0/18 (0.00%)  0
Psychiatric disorders     
delerium   1/14 (7.14%)  1 0/18 (0.00%)  0
Depression   0/14 (0.00%)  0 1/18 (5.56%)  1
Hallucinations   0/14 (0.00%)  0 1/18 (5.56%)  1
Renal and urinary disorders     
acute kidney injury *  0/14 (0.00%)  0 1/18 (5.56%)  1
Urinary Incontinence   0/14 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis   1/14 (7.14%)  1 0/18 (0.00%)  0
cough   0/14 (0.00%)  0 1/18 (5.56%)  1
Epistaxis   0/14 (0.00%)  0 1/18 (5.56%)  1
Hypoxia *  1/14 (7.14%)  1 0/18 (0.00%)  0
Postnasal drip   0/14 (0.00%)  0 1/18 (5.56%)  1
Respiratory Failure   0/14 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders     
alopecia   1/14 (7.14%)  1 0/18 (0.00%)  0
Erythroderma   1/14 (7.14%)  1 0/18 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome   3/14 (21.43%)  3 1/18 (5.56%)  1
Rash maculo-papular   3/14 (21.43%)  3 3/18 (16.67%)  3
Vascular disorders     
Hypertension *  3/14 (21.43%)  3 1/18 (5.56%)  1
Hypotension   1/14 (7.14%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: B. Douglas Smith
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: (410) 287-2935
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