S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00945815
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 35
• Locations: 81
• Arm: 1
• Duration (Months): 83
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: epratuzumab; Drug: clofarabine; Drug: cytarabine; Other: laboratory biomarker analysis	Phase 2

Detailed Description

OBJECTIVES:

• To test whether the complete remission (CR) rate (CR and incomplete CR) in adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to warrant further investigation.

• To estimate the frequency and severity of toxicities associated with the dosing schedule of cytarabine, clofarabine, and epratuzumab used in this study.

• To investigate, preliminarily, the effect of laboratory correlates (minimal post-treatment residual disease) and cytogenetic factors on prognosis in this patient population. (Not reported here due to limited MRD data)

OUTLINE: This is a multicenter study.

Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days 2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of disease progression or unacceptable toxicity*.

NOTE: * Prophylactic intrathecal methotrexate is required for patients < 22 years of age, and is recommended (but not required) for patients ≥ 22 years of age.

Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further laboratory analysis.

Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years after registration).

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment AraC 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 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle	Biological: epratuzumab; Drug: clofarabine; Drug: cytarabine; Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

1. Complete Remission [After induction therapy was completed (1 or 2 months)]

   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.

Secondary Outcome Measures

1. Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events [Up to 5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Morphologically confirmed precursor B-cell acute lymphoblastic leukemia (ALL) (non T-cell)

• Must have evidence of disease in bone marrow or peripheral blood

• Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell, or mixed B/T cell)

• Must have ≥ 5% lymphoblasts present in the blood or bone marrow

• At least 20% of marrow and/or peripheral blood lymphoblasts must be CD22+ by flow cytometry

• Co-expression of myeloid antigens (CD13 and CD33) allowed

• Patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible

• Philadelphia (Ph) chromosome-negative disease

• Patients with unknown Ph status by cytogenetics or FISH and unknown BCR/ABL status by PCR are eligible for study registration, but must be removed from study therapy if found to be Ph+ or BCR/ABL+ after study registration

• Refractory to a standard induction regimen that included vincristine and prednisone or high-dose cytarabine or mitoxantrone OR relapsed after successful prior induction therapy

• Any number of prior induction therapies or any number of remissions achieved are allowed

• No M0 acute myeloid leukemia, mixed lineage leukemia, or L3 (Burkitt) leukemia

• No active CNS involvement by clinical evaluation

• Patients with a documented history of CNS involvement of ALL or with clinical signs or symptoms consistent with CNS involvement of ALL must undergo a lumbar puncture that is negative for CNS involvement of ALL

• Patients < 22 years of age must be willing to receive prophylactic intrathecal chemotherapy

• Must be registered on SWOG-9007 "Cytogenetic Studies in Leukemia Patients" (closed as of 07/01/2010)

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• Bilirubin ≤ 1.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

• HIV-positive patients are eligible (at the discretion of the investigator) provided the following criteria are met:

• No history of AIDS-defining conditions

• CD4 cell count > 350/mm³

• If on antiretroviral agents, must not include zidovudine or stavudine

• Willing to receive prophylaxis for pneumocystis jirovecii pneumonia during study therapy (regardless of CD4 cell count) until the CD4 cell count is > 200/mm³ after completion of study treatment

• Prior malignancy (other than ALL) allowed provided it is in remission and there are no plans to treat the malignancy at the time of study registration

• No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs or symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment

• No neuropathy (cranial, motor or sensory) ≥ grade 2

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Any number of prior therapies allowed

• More than 90 days since prior allogeneic bone marrow transplant (BMT)

• No concurrent immunosuppression therapy for the treatment of graft-vs-host disease (GVHD)

• No acute GVHD ≥ grade 2, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity

• Prior autologous BMT allowed

• No concurrent immunosuppression therapy for the treatment of GVHD

• More than 14 days since prior chemotherapy, investigational agents, or major surgery and recovered

• Maintenance therapy with steroids, vincristine, and/or anti-metabolite agents, including but not limited to, mercaptopurine, thioguanine, and methotrexate allowed

• Concurrent hydroxyurea to reduce WBC to a reasonable level (as deemed by the treating physician) allowed

• No prior clofarabine or epratuzumab

• No other concurrent cytotoxic therapy or investigational therapy

• No concurrent alternative medications (e.g., herbal or botanical medications for anticancer purposes)

• Concurrent participation on SWOG-S9910 "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary" allowed (closed as of 07/01/2010)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
3	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
4	University of California Davis Cancer Center	Sacramento	California	United States	95817
5	Stanford Cancer Center	Stanford	California	United States	94305-5824
6	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
7	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
8	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida	United States	33612-9497
9	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
10	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
11	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
12	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
13	Hematology-Oncology Clinic	Baton Rouge	Louisiana	United States	70809
14	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
15	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
16	Saint Louis University Cancer Center	Saint Louis	Missouri	United States	63110
17	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
18	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
19	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
20	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
21	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
22	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
23	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
24	St. Peter's Hospital	Helena	Montana	United States	59601
25	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
26	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
27	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
28	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
29	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
30	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
31	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
32	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
33	Grandview Hospital	Dayton	Ohio	United States	45405
34	Good Samaritan Hospital	Dayton	Ohio	United States	45406
35	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
36	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
37	CCOP - Dayton	Dayton	Ohio	United States	45420
38	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
39	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
40	Wayne Hospital	Greenville	Ohio	United States	45331
41	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
42	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
43	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
44	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
45	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina	United States	29605
46	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina	United States	29605
47	CCOP - Greenville	Greenville	South Carolina	United States	29615
48	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina	United States	29650
49	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina	United States	29672
50	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
51	Baylor University Medical Center - Houston	Houston	Texas	United States	77030
52	Ben Taub General Hospital	Houston	Texas	United States	77030
53	St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
54	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
55	American Fork Hospital	American Fork	Utah	United States	84003
56	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
57	Logan Regional Hospital	Logan	Utah	United States	84321
58	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
59	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
60	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
61	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
62	LDS Hospital	Salt Lake City	Utah	United States	84143
63	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
64	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
65	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
66	Highline Medical Center Cancer Center	Burien	Washington	United States	98166
67	Swedish Medical Center - Issaquah Campus	Issaquah	Washington	United States	98029
68	Columbia Basin Hematology	Kennewick	Washington	United States	99336
69	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98274
70	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
71	Harborview Medical Center	Seattle	Washington	United States	98104
72	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
73	Group Health Central Hospital	Seattle	Washington	United States	98112
74	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
75	Polyclinic First Hill	Seattle	Washington	United States	98122
76	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
77	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
78	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
79	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
80	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
81	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Anjali Advani, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00945815
• Other Study ID Numbers: S0910; S0910; U10CA032102
• First Posted: Jul 24, 2009
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Southwest Oncology Group: B-cell adult acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; recurrent adult acute lymphoblastic leukemia
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Cytarabine; Clofarabine; Epratuzumab

Study Results

Participant Flow

Arm/Group Title	Ara-C + Clofarabine + Epratuzumab
Arm/Group Description	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.
Period Title: Overall Study
STARTED	35
Eligible	32
Eligible and Began Protocol Therapy	31
COMPLETED	27
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Ara-C + Clofarabine + Epratuzumab
Arm/Group Description	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 Participants	31
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	41
Sex: Female, Male (Count of Participants)
Female	8 25.8%
Male	23 74.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 35.5%
Not Hispanic or Latino	18 58.1%
Unknown or Not Reported	2 6.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 3.2%
White	26 83.9%
More than one race	0 0%
Unknown or Not Reported	3 9.7%

Outcome Measures

1. Secondary Outcome

Title	Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Description	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.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.

Arm/Group Title	Ara-C + Clofarabine + Epratuzumab
Arm/Group Description	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.
Measure Participants	31
Abdominal pain	1 3.2%
Acute kidney injury	1 3.2%
Alanine aminotransferase increased	5 16.1%
Alkaline phosphatase increased	1 3.2%
Anemia	6 19.4%
Anorexia	1 3.2%
Aspartate aminotransferase increased	6 19.4%
Cardiac arrest	2 6.5%
Catheter related infection	2 6.5%
Diarrhea	2 6.5%
Electrocardiogram QT corrected interval prolonged	1 3.2%
Encephalopathy	2 6.5%
Enterocolitis infectious	2 6.5%
Febrile neutropenia	17 54.8%
Gum infection	1 3.2%
Hepatic failure	1 3.2%
Hypercalcemia	1 3.2%
Hyperglycemia	1 3.2%
Hyperkalemia	1 3.2%
Hypertension	1 3.2%
Hypocalcemia	1 3.2%
Hypokalemia	1 3.2%
Hyponatremia	1 3.2%
Hypophosphatemia	1 3.2%
Hypotension	2 6.5%
Hypoxia	2 6.5%
Infections and infestations-Gram neg. bacteremia	1 3.2%
Investigations - Bacteremia	1 3.2%
Leukocytosis	1 3.2%
Lung infection	4 12.9%
Lymphocyte count decreased	4 12.9%
Nervous system disorders - subdural hematoma	1 3.2%
Neutrophil count decreased	9 29%
Oral pain	1 3.2%
Platelet count decreased	12 38.7%
Respiratory failure	1 3.2%
Sepsis	4 12.9%
Tooth infection	1 3.2%
Tumor lysis syndrome	1 3.2%
Typhlitis	2 6.5%
White blood cell decreased	8 25.8%

2. Primary Outcome

Title	Complete Remission
Description	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.
Time Frame	After induction therapy was completed (1 or 2 months)

Outcome Measure Data

Analysis Population Description

Eligible patients who began protocol therapy.

Arm/Group Title	Ara-C + Clofarabine + Epratuzumab
Arm/Group Description	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.
Measure Participants	31
Number (95% Confidence Interval) [percentage of participants]	52 167.7%

Adverse Events

Time Frame	Up to 5 years
Arm/Group Title	Ara-C + Clofarabine + Epratuzumab
Arm/Group Description	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.
All Cause Mortality
	Ara-C + Clofarabine + Epratuzumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ara-C + Clofarabine + Epratuzumab
	Affected / at Risk (%)	# Events
Total	15/31 (48.4%)
Blood and lymphatic system disorders
Anemia	1/31 (3.2%)
Febrile neutropenia	6/31 (19.4%)
Cardiac disorders
Cardiac arrest	2/31 (6.5%)
Gastrointestinal disorders
Abdominal pain	1/31 (3.2%)
Diarrhea	2/31 (6.5%)
Oral pain	1/31 (3.2%)
Typhlitis	1/31 (3.2%)
General disorders
Death NOS	1/31 (3.2%)
Hepatobiliary disorders
Hepatic failure	1/31 (3.2%)
Infections and infestations
Catheter related infection	3/31 (9.7%)
Enterocolitis infectious	1/31 (3.2%)
Lung infection	3/31 (9.7%)
Sepsis	4/31 (12.9%)
Tooth infection	1/31 (3.2%)
Investigations
Alanine aminotransferase increased	2/31 (6.5%)
Aspartate aminotransferase increased	2/31 (6.5%)
Investigations - Other, specify	1/31 (3.2%)
Neutrophil count decreased	1/31 (3.2%)
Platelet count decreased	2/31 (6.5%)
Metabolism and nutrition disorders
Hypocalcemia	1/31 (3.2%)
Hypokalemia	1/31 (3.2%)
Hyponatremia	1/31 (3.2%)
Hypophosphatemia	1/31 (3.2%)
Nervous system disorders
Encephalopathy	2/31 (6.5%)
Nervous system disorders - Other, specify	1/31 (3.2%)
Transient ischemic attacks	1/31 (3.2%)
Renal and urinary disorders
Acute kidney injury	1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/31 (3.2%)
Respiratory failure	2/31 (6.5%)
Vascular disorders
Hypotension	1/31 (3.2%)
Other (Not Including Serious) Adverse Events
	Ara-C + Clofarabine + Epratuzumab
	Affected / at Risk (%)	# Events
Total	27/31 (87.1%)
Blood and lymphatic system disorders
Anemia	10/31 (32.3%)
Febrile neutropenia	13/31 (41.9%)
Cardiac disorders
Sinus tachycardia	5/31 (16.1%)
Ear and labyrinth disorders
Ear pain	2/31 (6.5%)
Eye disorders
Blurred vision	2/31 (6.5%)
Eye disorders - Other, specify	2/31 (6.5%)
Gastrointestinal disorders
Abdominal pain	5/31 (16.1%)
Constipation	4/31 (12.9%)
Diarrhea	13/31 (41.9%)
Dysphagia	3/31 (9.7%)
Mucositis oral	8/31 (25.8%)
Nausea	19/31 (61.3%)
Vomiting	12/31 (38.7%)
General disorders
Chills	5/31 (16.1%)
Edema limbs	4/31 (12.9%)
Fatigue	12/31 (38.7%)
Fever	4/31 (12.9%)
Injection site reaction	2/31 (6.5%)
Localized edema	2/31 (6.5%)
Infections and infestations
Catheter related infection	2/31 (6.5%)
Enterocolitis infectious	2/31 (6.5%)
Gum infection	3/31 (9.7%)
Lung infection	2/31 (6.5%)
Papulopustular rash	2/31 (6.5%)
Sepsis	4/31 (12.9%)
Investigations
Activated partial thromboplastin time prolonged	3/31 (9.7%)
Alanine aminotransferase increased	10/31 (32.3%)
Alkaline phosphatase increased	11/31 (35.5%)
Aspartate aminotransferase increased	12/31 (38.7%)
Blood bilirubin increased	3/31 (9.7%)
Creatinine increased	2/31 (6.5%)
INR increased	2/31 (6.5%)
Lymphocyte count decreased	5/31 (16.1%)
Neutrophil count decreased	10/31 (32.3%)
Platelet count decreased	15/31 (48.4%)
Weight loss	4/31 (12.9%)
White blood cell decreased	9/31 (29%)
Metabolism and nutrition disorders
Anorexia	4/31 (12.9%)
Hyperglycemia	14/31 (45.2%)
Hyperkalemia	3/31 (9.7%)
Hypermagnesemia	3/31 (9.7%)
Hypernatremia	2/31 (6.5%)
Hypoalbuminemia	12/31 (38.7%)
Hypocalcemia	11/31 (35.5%)
Hypoglycemia	4/31 (12.9%)
Hypokalemia	8/31 (25.8%)
Hypomagnesemia	6/31 (19.4%)
Hyponatremia	5/31 (16.1%)
Musculoskeletal and connective tissue disorders
Back pain	2/31 (6.5%)
Chest wall pain	2/31 (6.5%)
Generalized muscle weakness	2/31 (6.5%)
Pain in extremity	5/31 (16.1%)
Nervous system disorders
Dizziness	3/31 (9.7%)
Headache	8/31 (25.8%)
Peripheral sensory neuropathy	4/31 (12.9%)
Psychiatric disorders
Anxiety	2/31 (6.5%)
Depression	2/31 (6.5%)
Hallucinations	2/31 (6.5%)
Insomnia	5/31 (16.1%)
Respiratory, thoracic and mediastinal disorders
Cough	6/31 (19.4%)
Dyspnea	3/31 (9.7%)
Epistaxis	3/31 (9.7%)
Sore throat	6/31 (19.4%)
Skin and subcutaneous tissue disorders
Dry skin	5/31 (16.1%)
Palmar-plantar erythrodysesthesia syndrome	2/31 (6.5%)
Pruritus	7/31 (22.6%)
Purpura	2/31 (6.5%)
Rash acneiform	2/31 (6.5%)
Rash maculo-papular	12/31 (38.7%)
Skin and subcutaneous tissue disorders - Other	2/31 (6.5%)
Skin ulceration	2/31 (6.5%)
Vascular disorders
Hematoma	3/31 (9.7%)
Hypertension	6/31 (19.4%)
Hypotension	2/31 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.