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Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01769209
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : October 9, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michaela Liedtke, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Adult Acute Lymphoblastic Leukemia (ALL)
Ph-positive Adult Acute Lymphoblastic Leukemia (ALL)
Recurrent Adult Acute Lymphoblastic Leukemia (ALL)
T-cell Adult Acute Lymphoblastic Leukemia (ALL)
Interventions Drug: Bortezomib
Drug: Doxorubicin hydrochloride (HCl)
Drug: PEG-Asparaginase
Drug: Vincristine sulfate
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate
Enrollment 18

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
37.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
4
  22.2%
Male
14
  77.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
10
  55.6%
Not Hispanic or Latino
8
  44.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
6
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Response Rate (RR)
Hide Description

Response Rate (RR) was determined as the sum of complete response (CR) and partial response (PR). Due to overlap, "complete response rate without platelet recovery" (CRp) is not included in Response Rate (RR). The outcome is reported as the total number without dispersion.

  • CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.
  • CRp = Meets all criteria for CR except platelet count.
  • PR = Meets all criteria for CR except bone marrow contains 5 to 25% leukemia cells.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  61.1%
2.Secondary Outcome
Title Complete Response (CR)
Hide Description

Complete response (CR) was determined the number of participants who achieved CR by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. CR is defined as:

  • CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.
  • Not CR = All statuses and conditions if less than or not as defined.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  61.1%
3.Secondary Outcome
Title Complete Response Without Platelet Recovery (CRp)
Hide Description

Complete response without platelet recovery (CR) was determined as the number of participants who achieved CRp by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. The outcome reflects only those subjects that meet all complete response (CR) criteria except platelet count; participants that meet all criteria including platelet count are not included in this outcome. CR and CRp are defined below.

  • CR =.No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.
  • CRp = Meets all criteria for CR except platelet count.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

Progression-free survival (PFS) was assessed as survival without progression at 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression.

Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease.

Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
3
  16.7%
5.Secondary Outcome
Title Failure-free Survival (FFS)
Hide Description

Failure-free survival (FFS) was assessed as survival without progression or the addition of another systemic therapy, at or within 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression is defined below.

Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease.

Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
3
  16.7%
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was assessed as participants remaining alive 2 years after induction therapy. The outcome is reported as the number of participants (without dispersion).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
5
  27.8%
7.Secondary Outcome
Title Related Adverse Events (Grade 3, 4, 5)
Hide Description Toxicity was assessed as related grade 3, 4, or 5 adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. The outcome is reported as the total numbers of events (without dispersion) by CTCAE Body System, and whether the event was a hematologic toxicity or non-hematologic toxicity.
Time Frame 45 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Events specifically defined per protocol as "Hematologic Toxicity" or"Non-hematologic Toxicity" are included under the specific Body System and as a Hematologic or Non-hematologic Toxicity.
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Treatment-related adverse events
Blood and Lymphatic System Disorders 109
Gastrointestinal Disorders 9
Hepatobiliary disorders 2
Infections and Infestations 17
Investigations 78
Metabolism and Nutrition Disorders 49
Nervous System Disorders 1
Respiratory, Thoracic and Mediastinal Disorders 1
Vascular Disorders 2
Hematologic Toxicity 63
Non-hematologic Toxicity 52
8.Secondary Outcome
Title Induction of Reactive Oxygen Species (ROS)
Hide Description Circulating acute lymphoblastic leukemia (ALL) blast cells were to be evaluated for the presence of reactive oxygen species (ROS).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Assay development was unsuccessful, and the assessment and analysis were not conducted for any samples.
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description:

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib + Chemotherapy
Hide Arm/Group Description

Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.

Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.

All-Cause Mortality
Bortezomib + Chemotherapy
Affected / at Risk (%)
Total   13/18 (72.22%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib + Chemotherapy
Affected / at Risk (%) # Events
Total   10/18 (55.56%)    
Blood and lymphatic system disorders   
Neutropenic fever (febrile neutropenia)  1  1/18 (5.56%)  1
Disseminated intravascular coagulation (DIC)  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Colon and caecum inflammation (typhilitis, colitis)  1  1/18 (5.56%)  1
Hepatobiliary disorders   
Hepatobilliary Disorders-Other, veno-occlusive disease  1  1/18 (5.56%)  1
Infections and infestations   
Septic shock (sepsis)  1  5/18 (27.78%)  5
Nervous system disorders   
Intracranial hemorrhage  1  1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (4.0)
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 0%
Bortezomib + Chemotherapy
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Neutropenic fever (febrile neutropenia)  1  5/18 (27.78%)  5
Neutropenia  1  13/18 (72.22%)  13
Lymphopenia  1  13/18 (72.22%)  13
Anemia  1  16/18 (88.89%)  16
Thrombocytopenia  1  12/18 (66.67%)  12
Cardiac disorders   
Heart palpitations (tachycardia)  1  3/18 (16.67%)  3
Heart failure (congestive heart failure)  1  2/18 (11.11%)  2
Ear and labyrinth disorders   
Decreased hearing (hearing impaired)  1  1/18 (5.56%)  1
Eye disorders   
Blurred vision  1  3/18 (16.67%)  3
Dry eyes  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Pancreatitis  1  1/18 (5.56%)  1
Vomiting (nausea)  1  13/18 (72.22%)  13
Mucositis oral  1  4/18 (22.22%)  4
Constipation  1  7/18 (38.89%)  7
Gastroesophageal reflux disease (GERD)  1  7/18 (38.89%)  7
Diarrhea  1  6/18 (33.33%)  6
Colon and caecum inflammation (typhilitis, colitis)  1  5/18 (27.78%)  5
Abdominal pain  1  10/18 (55.56%)  10
Perianal pain ( Anal pain)  1  2/18 (11.11%)  2
Rectal hemorrhage  1  2/18 (11.11%)  2
General disorders   
Swelling (edema)  1  9/18 (50.00%)  9
Fatigue  1  7/18 (38.89%)  7
Chills  1  2/18 (11.11%)  2
Hepatobiliary disorders   
Hepatobilliary Disorders-Other, liver abscess  1  1/18 (5.56%)  1
Infections and infestations   
Infections and infestations-Other,thrush  1  3/18 (16.67%)  3
Respiratory infections  1  8/18 (44.44%)  8
Infections and infestations-Other, Herpes simplex virus  1  2/18 (11.11%)  2
Septic shock (sepsis)  1  1/18 (5.56%)  1
Respiratory syncytial virus (RSV)  1  1/18 (5.56%)  1
Skin infection  1  3/18 (16.67%)  3
Infections and infestations-Other, Herpes simplex virus Line, sepsis  1  5/18 (27.78%)  5
Investigations   
Fibrinogen decreased  1  17/18 (94.44%)  17
Partial thromboplastin time (PTT) high  1  7/18 (38.89%)  7
Aspartate aminotransferase (AST) elevated  1  14/18 (77.78%)  14
Alanine aminotransferase (ALT) elevated  1  15/18 (83.33%)  15
Bilirubin elevated  1  11/18 (61.11%)  11
Alkaline Phosphatase elevated  1  9/18 (50.00%)  9
Gamma-glutamyl transferase (GGT) elevated  1  2/18 (11.11%)  2
Amylase high  1  3/18 (16.67%)  3
Lipase high  1  6/18 (33.33%)  6
Creatinine high  1  7/18 (38.89%)  7
Metabolism and nutrition disorders   
Apetite loss (anorexia)  1  5/18 (27.78%)  5
Hypoalbuminemia (Albumin low)  1  18/18 (100.00%)  18
Hypertriglyceridemia (Triglycerides high)  1  2/18 (11.11%)  2
Hypernatremia -Sodium high  1  2/18 (11.11%)  2
Hyponatremia -Sodium low  1  5/18 (27.78%)  5
Hypokalemia -Potassium low  1  12/18 (66.67%)  12
Hyperkalemia -Potassium high  1  1/18 (5.56%)  1
Hypomagnesemia -Magnesium low  1  9/18 (50.00%)  9
Hypocalcemia -Calcium low  1  13/18 (72.22%)  13
Hypophosphatemia -Phosphorus low  1  9/18 (50.00%)  9
Metabolism and Nutrition Disorders-Other Phosphorus high  1  1/18 (5.56%)  1
Hyperglycemia (Glucose high)  1  13/18 (72.22%)  13
Hypoglycemia -Glucose low  1  3/18 (16.67%)  3
Musculoskeletal and connective tissue disorders   
Leg weakness (generalized muscle weakness )  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorder - Other, musculoskeletal Pain  1  13/18 (72.22%)  13
Avascular necrosis (Bone infarct)  1  1/18 (5.56%)  1
Nervous system disorders   
Dizziness  1  3/18 (16.67%)  3
Peripheral motor neuropathy  1  2/18 (11.11%)  2
Peripheral sensory neuropathy  1  8/18 (44.44%)  8
Seizures  1  1/18 (5.56%)  1
Leukoencephalopathy  1  1/18 (5.56%)  1
Ataxia  1  1/18 (5.56%)  1
Restless leg (akathisia)  1  1/18 (5.56%)  1
Syncope  1  1/18 (5.56%)  1
Headache  1  13/18 (72.22%)  13
Intracranial hemorrhage  1  2/18 (11.11%)  2
Psychiatric disorders   
Insomnia  1  3/18 (16.67%)  3
Confusion  1  3/18 (16.67%)  3
Depression  1  2/18 (11.11%)  2
Anxiety  1  1/18 (5.56%)  1
Renal and urinary disorders   
Urinary retention  1  1/18 (5.56%)  1
Pain during urination (dysuria)  1  1/18 (5.56%)  1
Reproductive system and breast disorders   
Scrotal pain  1  1/18 (5.56%)  1
Vaginal hemorrhage  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/18 (11.11%)  2
Breath shortness (Dyspnea)  1  1/18 (5.56%)  1
Hiccups  1  2/18 (11.11%)  2
Chest pain (pleuritic pain)  1  1/18 (5.56%)  1
Nosebleed (Epistaxis)  1  3/18 (16.67%)  3
Skin and subcutaneous tissue disorders   
Rash  1  4/18 (22.22%)  4
Pruritus  1  2/18 (11.11%)  2
Skin ulceration -Lip lesion  1  1/18 (5.56%)  1
Vascular disorders   
High blood pressure (hypertension)  1  2/18 (11.11%)  2
Low blood pressure (hyportension)  1  5/18 (27.78%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Michaela Liedtke, MD
Organization: Stanford University Medical Center
Phone: 650-498-6000
Responsible Party: Michaela Liedtke, Stanford University
ClinicalTrials.gov Identifier: NCT01769209     History of Changes
Other Study ID Numbers: IRB-25596
NCI-2012-03094 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HEMALL0008 ( Other Identifier: OnCore Number )
IRB-25596 ( Other Identifier: Stanford IRB )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: September 12, 2018
Results First Posted: October 9, 2018
Last Update Posted: November 14, 2018