Trial Outcomes & Findings for Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia (NCT NCT01870596)
NCT ID: NCT01870596
Last Updated: 2016-09-01
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2016-09-01
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
14
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)
n=14 Participants
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)
n=18 Participants
Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsFor 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)
Outcome measures
| Measure |
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)
n=14 Participants
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)
n=18 Participants
Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Response Rate(CR/CRi) Rate
|
6 participants
|
9 participants
|
Adverse Events
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm B (Cytarabine)
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)
n=14 participants at risk
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)
n=18 participants at risk
Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Renal and urinary disorders
Acute Kidney Injusry
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.00%
0/14
|
11.1%
2/18 • Number of events 2
|
|
General disorders
death multi system organ failure
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)
n=14 participants at risk
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)
n=18 participants at risk
Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Investigations
ADVERSE_EVENTS 9362 9362-GA079-129 1 Investigations Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Aspartate aminotransferase increased
|
0.00%
0/14
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
alopecia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
anorexia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Atrial Fibrillation
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
delerium
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
diarrhea
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Psychiatric disorders
Depression
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
28.6%
4/14 • Number of events 4
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
General disorders
edema limbs
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
35.7%
5/14 • Number of events 5
|
38.9%
7/18 • Number of events 7
|
|
General disorders
fever
|
7.1%
1/14 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
2/14 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
4/14 • Number of events 4
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Vascular disorders
Hypertension
|
21.4%
3/14 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Number of events 1
|
27.8%
5/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/14
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Infusion related reaction
|
14.3%
2/14 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Investigations
INR increased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Lung infection
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis ora
|
35.7%
5/14 • Number of events 5
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
21.4%
3/14 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.4%
3/14 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Sinus Tachycardia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Skin Infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
Additional Information
B. Douglas Smith
Sidney Kimmel Comprehensive Cancer Center
Phone: (410) 287-2935
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60