Trial Outcomes & Findings for S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT00945815)
NCT ID: NCT00945815
Last Updated: 2017-11-06
Results Overview
Complete remission (CR) is defined as: \<5% marrow aspirate blasts. Blasts can be \>=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils \>= 1000/mcl; platelets \>100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be \<=100,000/mcl and/or ANC may be \<1,000/mcl.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
After induction therapy was completed (1 or 2 months)
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Ara-C + Clofarabine + Epratuzumab
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Eligible
|
32
|
|
Overall Study
Eligible and Began Protocol Therapy
|
31
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Ara-C + Clofarabine + Epratuzumab
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Not protocol specified
|
1
|
|
Overall Study
Ineligible
|
3
|
|
Overall Study
Did not begin protocol therapy
|
1
|
Baseline Characteristics
S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Ara-C + Clofarabine + Epratuzumab
n=31 Participants
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After induction therapy was completed (1 or 2 months)Population: Eligible patients who began protocol therapy.
Complete remission (CR) is defined as: \<5% marrow aspirate blasts. Blasts can be \>=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils \>= 1000/mcl; platelets \>100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be \<=100,000/mcl and/or ANC may be \<1,000/mcl.
Outcome measures
| Measure |
Ara-C + Clofarabine + Epratuzumab
n=31 Participants
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Complete Remission
|
52 percentage of participants
Interval 33.0 to 70.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.
Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Outcome measures
| Measure |
Ara-C + Clofarabine + Epratuzumab
n=31 Participants
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Abdominal pain
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Catheter related infection
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Diarrhea
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Electrocardiogram QT corrected interval prolonged
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Encephalopathy
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
White blood cell decreased
|
8 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Acute kidney injury
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Alanine aminotransferase increased
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Alkaline phosphatase increased
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Anemia
|
6 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Anorexia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Aspartate aminotransferase increased
|
6 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Cardiac arrest
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Enterocolitis infectious
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Febrile neutropenia
|
17 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Gum infection
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hepatic failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypercalcemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hyperglycemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hyperkalemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypertension
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypocalcemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypokalemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hyponatremia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypophosphatemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypotension
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hypoxia
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Infections and infestations-Gram neg. bacteremia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Investigations - Bacteremia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Leukocytosis
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Lung infection
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Lymphocyte count decreased
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Nervous system disorders - subdural hematoma
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Neutrophil count decreased
|
9 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Oral pain
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Platelet count decreased
|
12 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Respiratory failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Sepsis
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Tooth infection
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Tumor lysis syndrome
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Typhlitis
|
2 Participants
|
Adverse Events
Ara-C + Clofarabine + Epratuzumab
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ara-C + Clofarabine + Epratuzumab
n=31 participants at risk
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
19.4%
6/31 • Up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
6.5%
2/31 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • Up to 5 years
|
|
Gastrointestinal disorders
Typhlitis
|
3.2%
1/31 • Up to 5 years
|
|
General disorders
Death NOS
|
3.2%
1/31 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
3.2%
1/31 • Up to 5 years
|
|
Infections and infestations
Catheter related infection
|
9.7%
3/31 • Up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
3.2%
1/31 • Up to 5 years
|
|
Infections and infestations
Lung infection
|
9.7%
3/31 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
12.9%
4/31 • Up to 5 years
|
|
Infections and infestations
Tooth infection
|
3.2%
1/31 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
2/31 • Up to 5 years
|
|
Investigations
Investigations - Other, specify
|
3.2%
1/31 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
6.5%
2/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.2%
1/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
6.5%
2/31 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.2%
1/31 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
3.2%
1/31 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.5%
2/31 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Up to 5 years
|
Other adverse events
| Measure |
Ara-C + Clofarabine + Epratuzumab
n=31 participants at risk
Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
32.3%
10/31 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
41.9%
13/31 • Up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.1%
5/31 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
6.5%
2/31 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
6.5%
2/31 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
6.5%
2/31 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.1%
5/31 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
12.9%
4/31 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
13/31 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
9.7%
3/31 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
25.8%
8/31 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
61.3%
19/31 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
38.7%
12/31 • Up to 5 years
|
|
General disorders
Chills
|
16.1%
5/31 • Up to 5 years
|
|
General disorders
Edema limbs
|
12.9%
4/31 • Up to 5 years
|
|
General disorders
Fatigue
|
38.7%
12/31 • Up to 5 years
|
|
General disorders
Fever
|
12.9%
4/31 • Up to 5 years
|
|
General disorders
Injection site reaction
|
6.5%
2/31 • Up to 5 years
|
|
General disorders
Localized edema
|
6.5%
2/31 • Up to 5 years
|
|
Infections and infestations
Catheter related infection
|
6.5%
2/31 • Up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
6.5%
2/31 • Up to 5 years
|
|
Infections and infestations
Gum infection
|
9.7%
3/31 • Up to 5 years
|
|
Infections and infestations
Lung infection
|
6.5%
2/31 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
6.5%
2/31 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
12.9%
4/31 • Up to 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.7%
3/31 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
32.3%
10/31 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
35.5%
11/31 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
38.7%
12/31 • Up to 5 years
|
|
Investigations
Blood bilirubin increased
|
9.7%
3/31 • Up to 5 years
|
|
Investigations
Creatinine increased
|
6.5%
2/31 • Up to 5 years
|
|
Investigations
INR increased
|
6.5%
2/31 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
16.1%
5/31 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
32.3%
10/31 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
48.4%
15/31 • Up to 5 years
|
|
Investigations
Weight loss
|
12.9%
4/31 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
29.0%
9/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.9%
4/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.2%
14/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.7%
3/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.7%
3/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.5%
2/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.7%
12/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
35.5%
11/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.9%
4/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.8%
8/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
19.4%
6/31 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.1%
5/31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.5%
2/31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
2/31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.1%
5/31 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Up to 5 years
|
|
Nervous system disorders
Headache
|
25.8%
8/31 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.9%
4/31 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • Up to 5 years
|
|
Psychiatric disorders
Hallucinations
|
6.5%
2/31 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
16.1%
5/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.7%
3/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.7%
3/31 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
19.4%
6/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.1%
5/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.5%
2/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.6%
7/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.5%
2/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.5%
2/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.7%
12/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.5%
2/31 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.5%
2/31 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
9.7%
3/31 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
19.4%
6/31 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
6.5%
2/31 • Up to 5 years
|
Additional Information
SWOG Leukemia Statistician
SWOG Statistical Center
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place