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Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma

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: NCT00764517
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : November 13, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephen Spurgeon, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Recurrent Indolent Adult Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Interventions Drug: Cladribine
Other: Laboratory Biomarker Analysis
Biological: Rituximab
Drug: Vorinostat
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 39 18
Completed 24 4
Not Completed 15 14
Reason Not Completed
Adverse Event             9             3
Death             3             11
Physician Decision             3             0
Arm/Group Title Previously Untreated Relapsed Total
Hide Arm/Group Description

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Total of all reporting groups
Overall Number of Baseline Participants 39 18 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants 18 participants 57 participants
62
(35 to 87)
60
(46 to 85)
61.5
(35 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 18 participants 57 participants
Female
5
  12.8%
3
  16.7%
8
  14.0%
Male
34
  87.2%
15
  83.3%
49
  86.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 18 participants 57 participants
Hispanic or Latino
2
   5.1%
0
   0.0%
2
   3.5%
Not Hispanic or Latino
37
  94.9%
18
 100.0%
55
  96.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 18 participants 57 participants
American Indian or Alaska Native
1
   2.6%
0
   0.0%
1
   1.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
37
  94.9%
18
 100.0%
55
  96.5%
More than one race
1
   2.6%
0
   0.0%
1
   1.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 18 participants 57 participants
39
 100.0%
18
 100.0%
57
 100.0%
1.Primary Outcome
Title Objective Response Rate
Hide Description ORR defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR). Assessed per the revised Cheson criteria. Response definitions per revised International Working Group Response Criteria. 95% confidence interval will be provided. Definitions: Complete response (CR) = disappearance of all evidence of disease; Partial response (PR) = regression of measurable disease and no new sites.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 39 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97
(87 to 100)
39
(17 to 64)
2.Primary Outcome
Title Toxicities as Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hide Description Toxicity is determined percentage of patients that experienced an adverse event (AE) grade 3 or higher during the time frame, assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade refers to the severity of the AE increasing from Grade 1 to 5. Generally, Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 39 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90
(76 to 97)
83
(59 to 96)
3.Primary Outcome
Title Tolerability of Treatment
Hide Description Tolerability is determined to be the percentage of patients who completed the full duration of treatment (all 6 cycles) regardless of adverse event status. % tolerability shows the rate of patients that tolerated the treatment for the full duration.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 39 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62
(45 to 77)
22
(6 to 48)
4.Secondary Outcome
Title Progression-free Survival
Hide Description

Time from treatment start until disease progression or death.

Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 39 18
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25 to NA)
19.5
(2 to 33)
[1]
Median survival not reached. Upper confidence limit is inestimable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previously Untreated, Relapsed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.16 to 0.69
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Event-free Survival
Hide Description

Time from treatment start until disease progression, death, or discontinuation of treatment for adverse event (toxicity)

Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 39 18
Median (95% Confidence Interval)
Unit of Measure: Months
39.0 [1] 
(25 to NA)
19.5
(2.0 to 34.0)
[1]
Upper confidence limit is inestimatable
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previously Untreated, Relapsed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.21 to 0.84
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Contribution (if Any) of DNA Methylation/Histone Deacetylation
Hide Description

Determine the contribution (if any) of DNA methylation/histone deacetylation to disease progression and/or response to SCR combination chemotherapy.

Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected and the outcome will never be analyzed.
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Scientific Correlates
Hide Description

Perform scientific correlates to determine if SCR treatment a) is associated with global and gene specific changes in transcription of mRNAs and MiRNAs b) is acting as an inhibitor of DNA methylation c) is activating or silencing specific genes or miRNAs.

Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected and the outcome will never be analyzed.
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description:

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 25 weeks (6 cycles X 28 days + 1 week after last cycle. Toxicities and adverse experiences will be assessed at each visit using the NCI Common Terminology Criteria for Adverse Events v4.0. Adverse events evaluated and recorded using the NCI CTCAE, Version 4.0 for 1 week after last cycle.
Adverse Event Reporting Description

For reporting purposes here, Grade 4 will be considered to be serious adverse event (SAE).

Events assessed at each visit during the study (every other week for Cycle 1, then monthly for Cycles 2 to 6)

 
Arm/Group Title Previously Untreated Relapsed
Hide Arm/Group Description

Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].

Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

All-Cause Mortality
Previously Untreated Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   8/39 (20.51%)      13/18 (72.22%)    
Hide Serious Adverse Events
Previously Untreated Relapsed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/39 (46.15%)      9/18 (50.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Febrile neutropenia  1  4/39 (10.26%)  4 1/18 (5.56%)  1
General disorders     
Death NOS  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Immune system disorders     
Allergic reaction  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Aspartate aminotransferase increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Cardiac troponin I increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
INR increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Neutrophil count decreased  1  9/39 (23.08%)  10 4/18 (22.22%)  4
Platelet count decreased  1  4/39 (10.26%)  4 4/18 (22.22%)  4
Metabolism and nutrition disorders     
Hyperglycemia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Hypokalemia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Respiratory failure  1  0/39 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, NCI CTCAE 4.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Previously Untreated Relapsed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/39 (71.79%)      14/18 (77.78%)    
Blood and lymphatic system disorders     
Anemia  1  3/39 (7.69%)  3 1/18 (5.56%)  1
Febrile neutropenia  1  9/39 (23.08%)  11 5/18 (27.78%)  5
Cardiac disorders     
Aortic valve disease  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Atrial fibrillation  1  0/39 (0.00%)  0 1/18 (5.56%)  1
heart failure  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Supraventricular tachycardia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Gastric hemorrhage  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Vomiting  1  1/39 (2.56%)  1 0/18 (0.00%)  0
General disorders     
Fatigue  1  5/39 (12.82%)  5 2/18 (11.11%)  2
Infusion related reaction  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Pain  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Infection: pulmonary (lung)  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Alanine aminotransferase increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Aspartate aminotransferase increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Cardiac troponin I increased  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Hemoglobin decreased  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Hemoglobin increased  1  0/39 (0.00%)  0 2/18 (11.11%)  2
INR increased  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Neutrophil count decreased  1  7/39 (17.95%)  8 5/18 (27.78%)  6
Platelet count decreased  1  14/39 (35.90%)  15 5/18 (27.78%)  5
Weight loss  1  2/39 (5.13%)  2 1/18 (5.56%)  1
Metabolism and nutrition disorders     
Anorexia  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Hyperglycemia  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Hyperkalemia  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Hypocalcemia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Hypokalemia  1  2/39 (5.13%)  2 1/18 (5.56%)  1
Hyponatremia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Hypophosphatemia  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Dizziness  1  1/39 (2.56%)  1 1/18 (5.56%)  1
Headache  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Syncope  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Urinary frequency  1  1/39 (2.56%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/39 (5.13%)  2 0/18 (0.00%)  0
Hypoxia  1  0/39 (0.00%)  0 1/18 (5.56%)  1
Vascular disorders     
Hypotension  1  2/39 (5.13%)  3 0/18 (0.00%)  0
Thromboembolic event  1  2/39 (5.13%)  2 0/18 (0.00%)  0
1
Term from vocabulary, NCI CTCAE 4.0
Indicates events were collected by systematic assessment
Secondary objectives and outcomes not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Stephen E. Spurgeon MD
Organization: Knight Cancer Institute, Oregon Health & Science University
Phone: 503-494-4606
EMail: spurgeos@ohsu.edu
Layout table for additonal information
Responsible Party: Stephen Spurgeon, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00764517    
Other Study ID Numbers: IRB00004180
NCI-2011-03737 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4180 ( Other Identifier: OHSU IRB )
HEM-08002-L ( Other Identifier: OHSU Knight Cancer Insitute )
CR00021415
IRB00004180 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2008
First Posted: October 2, 2008
Results First Submitted: August 31, 2017
Results First Posted: November 13, 2017
Last Update Posted: December 11, 2017