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Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas

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: NCT01193842
Recruitment Status : Active, not recruiting
First Posted : September 2, 2010
Results First Posted : June 12, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions AIDS-Related Plasmablastic Lymphoma
AIDS-Related Primary Effusion Lymphoma
Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Ann Arbor Stage I Grade 3 Follicular Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Ann Arbor Stage III Grade 3 Follicular Lymphoma
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
Ann Arbor Stage IV Grade 3 Follicular Lymphoma
HIV Infection
Plasmablastic Lymphoma
Primary Effusion Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Interventions Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine Sulfate
Drug: Vorinostat
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1) Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2) Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual. Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle) Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Period Title: Phase I: VR-DA-EPOCH, Dose Level (DL) 1
Started 3 0 0 0 0
Completed 3 0 0 0 0
Not Completed 0 0 0 0 0
Period Title: Phase I: VR-DA-EPOCH, DL 2
Started 0 7 0 0 0
Completed 0 6 0 0 0
Not Completed 0 1 0 0 0
Reason Not Completed
Ineligible             0             1             0             0             0
Period Title: Phase I: VR-DA-EPOCH, DL 1 (De-escalate)
Started 4 0 0 0 0
Completed 3 0 0 0 0
Not Completed 1 0 0 0 0
Reason Not Completed
Ineligible             1             0             0             0             0
Period Title: Phase I: VR-CHOP, DL 1
Started 0 0 2 0 0
Completed 0 0 1 0 0
Not Completed 0 0 1 0 0
Reason Not Completed
Noncompliant (Cycle 1 not complete)             0             0             1             0             0
Period Title: Phase II: Randomized Groups
Started 0 0 0 45 46
Completed 0 0 0 33 36
Not Completed 0 0 0 12 10
Reason Not Completed
Death             0             0             0             1             1
Adverse Event             0             0             0             5             3
Withdrawal by Subject             0             0             0             1             2
Ineligible             0             0             0             0             1
Disease progression/relapse on treatment             0             0             0             5             3
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II, V+DA-EPOCH Phase II, DA-R-EPOCH Total
Hide Arm/Group Description Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1) Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2) Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual. Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle) Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat Total of all reporting groups
Overall Number of Baseline Participants 6 6 1 45 45 103
Hide Baseline Analysis Population Description
Eligible participants completing at least one cycle of treatment; 3 ineligible participants and 1 participant not completing one cycle of Phase I treatment were not included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 1 participants 45 participants 45 participants 103 participants
45.7  (12.4) 50.4  (10.1) 59.5  (0) 49.2  (10.1) 45  (9.2) 47.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 1 participants 45 participants 45 participants 103 participants
Female
0
   0.0%
1
  16.7%
0
   0.0%
6
  13.3%
0
   0.0%
7
   6.8%
Male
6
 100.0%
5
  83.3%
1
 100.0%
39
  86.7%
45
 100.0%
96
  93.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 1 participants 45 participants 45 participants 103 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
0
   0.0%
14
  31.1%
13
  28.9%
29
  28.2%
Not Hispanic or Latino
5
  83.3%
5
  83.3%
1
 100.0%
29
  64.4%
30
  66.7%
70
  68.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.4%
2
   4.4%
4
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 1 participants 45 participants 45 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   1.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.4%
1
   2.2%
3
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
0
   0.0%
0
   0.0%
12
  26.7%
8
  17.8%
22
  21.4%
White
4
  66.7%
6
 100.0%
1
 100.0%
23
  51.1%
31
  68.9%
65
  63.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
8
  17.8%
4
   8.9%
12
  11.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 1 participants 45 participants 45 participants 103 participants
6
 100.0%
6
 100.0%
1
 100.0%
45
 100.0%
45
 100.0%
103
 100.0%
1.Primary Outcome
Title Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
Hide Description Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Reviewed responses from participants who completed at least one cycle of treatment.
Arm/Group Title Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Overall Number of Participants Analyzed 40 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.5
(50.9 to 81.4)
76.2
(60.6 to 88.0)
2.Primary Outcome
Title Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Hide Description The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized participants
Arm/Group Title Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: percentage of participants
Death 28.9 20.0
Life-threatening 37.8 28.9
Severe 20.0 31.1
Moderate 8.9 17.8
Mild 2.2 0
3.Primary Outcome
Title Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
Hide Description Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5.
Arm/Group Title Phase I: VR-DA-EPOCH
Hide Arm/Group Description:
Phase I, Arm A (VR-DA-EPOCH)
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Mg per day of Vorinostat
300
4.Secondary Outcome
Title Change in CD8 Cell Counts (Phase I)
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who returned for follow-up with evaluable data.
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1
Hide Arm/Group Description:
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
Overall Number of Participants Analyzed 4 5 1
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
End of cycle 2 Number Analyzed 4 participants 5 participants 1 participants
35.5
(-348.5 to 356.5)
-115
(-162 to 75)
-172
(-172 to -172)
Treatment discontinuation Number Analyzed 4 participants 5 participants 1 participants
-164.5
(-962.5 to 198.5)
211
(18 to 359)
-81
(-81 to -81)
6-month follow-up Number Analyzed 3 participants 5 participants 1 participants
-56
(-177 to 443)
275
(-152 to 728)
-16
(-16 to -16)
12-month follow-up Number Analyzed 1 participants 5 participants 1 participants
604
(604 to 604)
154
(-97 to 692)
128
(128 to 128)
5.Secondary Outcome
Title Changes in Absolute CD4 Cell Counts (Phase I)
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who completed at least 1 cycle of treatment with evaluable data.
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1
Hide Arm/Group Description:
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Phase I, Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
Overall Number of Participants Analyzed 6 6 1
Median (Inter-Quartile Range)
Unit of Measure: cell/mm^3
End of cycle 2 Number Analyzed 6 participants 6 participants 1 participants
92
(9 to 143)
-9
(-41 to 49)
-218
(-218 to -218)
Treatment discontinuation Number Analyzed 6 participants 5 participants 1 participants
-39
(-53 to 56)
-29
(-32 to 41)
-190
(-190 to -190)
6-month follow-up Number Analyzed 3 participants 5 participants 1 participants
76
(75 to 181)
31
(-9 to 45)
-175
(-175 to -175)
12-month follow-up Number Analyzed 1 participants 5 participants 1 participants
169
(169 to 169)
31
(-16 to 104)
-84
(-84 to -84)
6.Secondary Outcome
Title Changes in Epstein-Barr Virus (EBV) Viral Load
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.
Time Frame Baseline up to 12 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Changes in Human Herpes Virus (HHV)-8 Viral Load
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.
Time Frame Baseline up to 12 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Changes in Human Immunodeficiency Virus (HIV) Viral Load
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II participants who returned for follow-up with evaluable data.
Arm/Group Title Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Overall Number of Participants Analyzed 42 41
Median (Inter-Quartile Range)
Unit of Measure: copies per milliliter
End of Cycle 2 Number Analyzed 42 participants 41 participants
-20
(-22607 to 0)
-25
(-3308 to 0)
At treatment discontinuation Number Analyzed 42 participants 40 participants
-87
(-28176 to 0)
-22.5
(-1962 to 4.5)
6-month follow-up Number Analyzed 42 participants 26 participants
-20
(-24703 to 0)
-18
(-3258 to 0)
12-month follow-up Number Analyzed 42 participants 23 participants
0
(-22656 to 20)
-20
(-3361 to 0)
9.Secondary Outcome
Title Event-free Survival (EFS) (Phase II)
Hide Description The percentage of participants surviving without events (relapse or death) one year after starting treatment.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized participants.
Arm/Group Title Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.6
(63.0 to 88.1)
82.2
(71.1 to 93.4)
10.Secondary Outcome
Title Overall Survival (OS) (Phase II)
Hide Description The percentage of participants surviving one year after starting treatment.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized participants.
Arm/Group Title Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.6
(65.3 to 89.8)
86.7
(76.7 to 96.6)
11.Secondary Outcome
Title Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
Hide Description Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who returned for follow-up with evaluable data.
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1
Hide Arm/Group Description:
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Phase I, Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
Overall Number of Participants Analyzed 6 6 1
Median (Inter-Quartile Range)
Unit of Measure: copies per milliliter
End of cycle 2 Number Analyzed 6 participants 6 participants 1 participants
-14518
(-54352 to 0)
-12.5
(-66 to 0)
28
(28 to 28)
Treatment discontinuation Number Analyzed 6 participants 5 participants 1 participants
-4517
(-55116 to 0)
0
(-88 to 49)
0
(0 to 0)
6-month follow-up Number Analyzed 3 participants 5 participants 1 participants
-55116
(-282977 to 0)
0
(-88 to 0)
0
(0 to 0)
12-month follow-up Number Analyzed 1 participants 5 participants 1 participants
0
(0 to 0)
0
(-88 to 0)
0
(0 to 0)
12.Secondary Outcome
Title Pharmacokinetic Clearance (Phase I)
Hide Description Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.
Time Frame 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I participants with evaluable pharmacokinetic data
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
Overall Number of Participants Analyzed 6 5 0
Mean (Standard Deviation)
Unit of Measure: Liter/hour
Doxorubicin 78.6  (48.0) 76.0  (47.9)
Etoposide 3.0  (1.6) 2.4  (0.7)
Vincristine 22.4  (10.2) 16.8  (8.9)
13.Secondary Outcome
Title Tumor Response (Phase I)
Hide Description The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
Time Frame Up to 2 years post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who completed at least 1 cycle of treatment.
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: Arm C (VR-CHOP) Dose Level 1
Hide Arm/Group Description:
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
Overall Number of Participants Analyzed 6 6 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Complete response
83.3
(35.9 to 99.6)
83.3
(35.9 to 99.6)
100
(2.5 to 100)
Partial Response
16.7
(0.4 to 64.1)
16.7
(0.4 to 64.1)
0
(0 to 97.5)
Time Frame Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Hide Arm/Group Description Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1) Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2) Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual. Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle) Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat
All-Cause Mortality
Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)   1/7 (14.29%)   0/2 (0.00%)   13/45 (28.89%)   9/46 (19.57%) 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   3/7 (42.86%)   0/2 (0.00%)   25/45 (55.56%)   21/46 (45.65%) 
Blood and lymphatic system disorders           
Febrile Neutropenia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  10/45 (22.22%)  8/46 (17.39%) 
Anemia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  2/46 (4.35%) 
Cardiac disorders           
Atrial Fibrillation * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Cardiac Arrest * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  3/45 (6.67%)  2/46 (4.35%) 
Cardiac Disorders - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Pericardial Effusion * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain * 1  2/7 (28.57%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  1/46 (2.17%) 
Colitis * 1  2/7 (28.57%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Diarrhea * 1  2/7 (28.57%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Esophageal Ulcer * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Esophagitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Gastric Hemorrhage * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Intra-Abdominal Hemorrhage * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Mucositis Oral * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Nausea * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  1/46 (2.17%) 
Rectal Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Small Intestinal Obstruction * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Vomiting * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  3/46 (6.52%) 
General disorders           
Death Nos * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Fatigue * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Multi-Organ Failure * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Non-Cardiac Chest Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Infections and infestations           
Enterocolitis Infectious * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Infections And Infestations - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Kidney Infection * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Lung Infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  2/46 (4.35%) 
Sepsis * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  3/46 (6.52%) 
Soft Tissue Infection * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Tooth Infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Urinary Tract Infection * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Injury, poisoning and procedural complications           
Spinal Fracture * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Investigations           
Alanine Aminotransferase Increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Lymphocyte Count Decreased * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  0/46 (0.00%) 
Neutrophil Count Decreased * 1  5/7 (71.43%)  2/7 (28.57%)  0/2 (0.00%)  12/45 (26.67%)  2/46 (4.35%) 
Platelet Count Decreased * 1  0/7 (0.00%)  3/7 (42.86%)  0/2 (0.00%)  11/45 (24.44%)  0/46 (0.00%) 
White Blood Cell Decreased * 1  5/7 (71.43%)  0/7 (0.00%)  0/2 (0.00%)  5/45 (11.11%)  1/46 (2.17%) 
Metabolism and nutrition disorders           
Dehydration * 1  1/7 (14.29%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Hyperglycemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  7/45 (15.56%)  4/46 (8.70%) 
Nervous system disorders           
Encephalopathy * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  0/46 (0.00%) 
Headache * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Nervous System Disorders - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Psychiatric disorders           
Delirium * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Renal and urinary disorders           
Acute Kidney Injury * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Renal And Urinary Disorders - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Renal Colic * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnea * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  0/46 (0.00%) 
Pneumonitis * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Respiratory Failure * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Surgical and medical procedures           
Surgical And Medical Procedures - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Vascular disorders           
Thromboembolic Event * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
1
Term from vocabulary, NCI CTCAE 4.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: VR-DA-EPOCH, Dose Level 1 Phase I: VR-DA-EPOCH, Dose Level 2 Phase I: VR-CHOP, Dose Level 1 Phase II: VR-DA-EPOCH Phase II: DA-R-EPOCH
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   6/7 (85.71%)   2/2 (100.00%)   43/45 (95.56%)   43/46 (93.48%) 
Blood and lymphatic system disorders           
Anemia * 1  2/7 (28.57%)  4/7 (57.14%)  1/2 (50.00%)  27/45 (60.00%)  23/46 (50.00%) 
Febrile Neutropenia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  0/46 (0.00%) 
Leukocytosis * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  1/46 (2.17%) 
Cardiac disorders           
Pericarditis * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Sinus Tachycardia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  2/46 (4.35%) 
Eye disorders           
Watering Eyes * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain * 1  1/7 (14.29%)  1/7 (14.29%)  0/2 (0.00%)  8/45 (17.78%)  4/46 (8.70%) 
Anal Mucositis * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Colitis * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  3/46 (6.52%) 
Constipation * 1  3/7 (42.86%)  2/7 (28.57%)  0/2 (0.00%)  20/45 (44.44%)  18/46 (39.13%) 
Diarrhea * 1  3/7 (42.86%)  1/7 (14.29%)  0/2 (0.00%)  17/45 (37.78%)  10/46 (21.74%) 
Dyspepsia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  2/46 (4.35%) 
Esophagitis * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Gastroesophageal Reflux Disease * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  3/46 (6.52%) 
Gastrointestinal Disorders - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  3/46 (6.52%) 
Mucositis Oral * 1  2/7 (28.57%)  2/7 (28.57%)  0/2 (0.00%)  9/45 (20.00%)  9/46 (19.57%) 
Nausea * 1  6/7 (85.71%)  3/7 (42.86%)  1/2 (50.00%)  20/45 (44.44%)  22/46 (47.83%) 
Vomiting * 1  2/7 (28.57%)  1/7 (14.29%)  1/2 (50.00%)  10/45 (22.22%)  9/46 (19.57%) 
General disorders           
Chills * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  5/45 (11.11%)  0/46 (0.00%) 
Edema Limbs * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  10/45 (22.22%)  4/46 (8.70%) 
Fatigue * 1  2/7 (28.57%)  2/7 (28.57%)  2/2 (100.00%)  18/45 (40.00%)  13/46 (28.26%) 
Fever * 1  0/7 (0.00%)  2/7 (28.57%)  0/2 (0.00%)  8/45 (17.78%)  2/46 (4.35%) 
Flu Like Symptoms * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
General Disorders And Administration Site Conditions - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  3/46 (6.52%) 
Infusion Related Reaction * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  2/46 (4.35%) 
Non-Cardiac Chest Pain * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  1/46 (2.17%) 
Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  3/46 (6.52%) 
Infections and infestations           
Abdominal Infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Esophageal Infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Infections And Infestations - Other, Specify * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  5/45 (11.11%)  0/46 (0.00%) 
Mucosal Infection * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  1/45 (2.22%)  4/46 (8.70%) 
Nail Infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  1/46 (2.17%) 
Rhinitis Infective * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Upper Respiratory Infection * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  2/45 (4.44%)  2/46 (4.35%) 
Injury, poisoning and procedural complications           
Seroma * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Investigations           
Alanine Aminotransferase Increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  18/45 (40.00%)  9/46 (19.57%) 
Alkaline Phosphatase Increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  11/45 (24.44%)  9/46 (19.57%) 
Aspartate Aminotransferase Increased * 1  1/7 (14.29%)  1/7 (14.29%)  0/2 (0.00%)  15/45 (33.33%)  10/46 (21.74%) 
Blood Bilirubin Increased * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  2/46 (4.35%) 
Creatinine Increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  4/46 (8.70%) 
Ggt Increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  3/46 (6.52%) 
Lymphocyte Count Decreased * 1  1/7 (14.29%)  3/7 (42.86%)  1/2 (50.00%)  20/45 (44.44%)  19/46 (41.30%) 
Lymphocyte Count Increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  2/46 (4.35%) 
Neutrophil Count Decreased * 1  4/7 (57.14%)  2/7 (28.57%)  0/2 (0.00%)  24/45 (53.33%)  19/46 (41.30%) 
Platelet Count Decreased * 1  4/7 (57.14%)  3/7 (42.86%)  1/2 (50.00%)  27/45 (60.00%)  19/46 (41.30%) 
Weight Loss * 1  1/7 (14.29%)  1/7 (14.29%)  0/2 (0.00%)  3/45 (6.67%)  0/46 (0.00%) 
White Blood Cell Decreased * 1  3/7 (42.86%)  2/7 (28.57%)  0/2 (0.00%)  25/45 (55.56%)  21/46 (45.65%) 
Metabolism and nutrition disorders           
Anorexia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  4/46 (8.70%) 
Hyperglycemia * 1  0/7 (0.00%)  2/7 (28.57%)  0/2 (0.00%)  23/45 (51.11%)  16/46 (34.78%) 
Hyperkalemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  4/46 (8.70%) 
Hypernatremia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  2/46 (4.35%) 
Hypertriglyceridemia * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  2/46 (4.35%) 
Hyperuricemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  4/46 (8.70%) 
Hypoalbuminemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  14/45 (31.11%)  15/46 (32.61%) 
Hypocalcemia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  11/45 (24.44%)  16/46 (34.78%) 
Hypoglycemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  5/46 (10.87%) 
Hypokalemia * 1  2/7 (28.57%)  1/7 (14.29%)  0/2 (0.00%)  23/45 (51.11%)  15/46 (32.61%) 
Hypomagnesemia * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  6/45 (13.33%)  7/46 (15.22%) 
Hyponatremia * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  14/45 (31.11%)  10/46 (21.74%) 
Hypophosphatemia * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  7/45 (15.56%)  8/46 (17.39%) 
Musculoskeletal and connective tissue disorders           
Back Pain * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  4/45 (8.89%)  0/46 (0.00%) 
Bone Pain * 1  1/7 (14.29%)  0/7 (0.00%)  1/2 (50.00%)  2/45 (4.44%)  4/46 (8.70%) 
Chest Wall Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  4/46 (8.70%) 
Muscle Weakness Lower Limb * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  0/46 (0.00%) 
Myalgia * 1  2/7 (28.57%)  0/7 (0.00%)  0/2 (0.00%)  3/45 (6.67%)  1/46 (2.17%) 
Neck Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  3/46 (6.52%) 
Nervous system disorders           
Cognitive Disturbance * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Dizziness * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  6/45 (13.33%)  5/46 (10.87%) 
Dysesthesia * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Headache * 1  2/7 (28.57%)  0/7 (0.00%)  0/2 (0.00%)  9/45 (20.00%)  17/46 (36.96%) 
Paresthesia * 1  0/7 (0.00%)  0/7 (0.00%)  1/2 (50.00%)  3/45 (6.67%)  3/46 (6.52%) 
Peripheral Motor Neuropathy * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  2/46 (4.35%) 
Peripheral Sensory Neuropathy * 1  2/7 (28.57%)  1/7 (14.29%)  0/2 (0.00%)  12/45 (26.67%)  20/46 (43.48%) 
Dysgeusia * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  5/45 (11.11%)  1/46 (2.17%) 
Psychiatric disorders           
Anxiety * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  5/45 (11.11%)  3/46 (6.52%) 
Depression * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  2/46 (4.35%) 
Insomnia * 1  1/7 (14.29%)  1/7 (14.29%)  0/2 (0.00%)  5/45 (11.11%)  7/46 (15.22%) 
Renal and urinary disorders           
Urinary Frequency * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  2/45 (4.44%)  4/46 (8.70%) 
Urinary Tract Pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  3/46 (6.52%) 
Reproductive system and breast disorders           
Oligospermia * 1  0/7 (0.00%)  0/7 (0.00%)  1/2 (50.00%)  0/45 (0.00%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Allergic Rhinitis * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  4/46 (8.70%) 
Cough * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  10/46 (21.74%) 
Dyspnea * 1  1/7 (14.29%)  0/7 (0.00%)  1/2 (50.00%)  4/45 (8.89%)  3/46 (6.52%) 
Hiccups * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  1/45 (2.22%)  2/46 (4.35%) 
Hoarseness * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  3/46 (6.52%) 
Hyperhidrosis * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia * 1  1/7 (14.29%)  0/7 (0.00%)  1/2 (50.00%)  4/45 (8.89%)  6/46 (13.04%) 
Bullous Dermatitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Dry Skin * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  1/46 (2.17%) 
Nail Discoloration * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  1/46 (2.17%) 
Pruritus * 1  0/7 (0.00%)  1/7 (14.29%)  0/2 (0.00%)  0/45 (0.00%)  2/46 (4.35%) 
Rash Maculo-Papular * 1  0/7 (0.00%)  2/7 (28.57%)  0/2 (0.00%)  2/45 (4.44%)  2/46 (4.35%) 
Vascular disorders           
Flushing * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
Hypertension * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  4/45 (8.89%)  3/46 (6.52%) 
Hypotension * 1  0/7 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  4/46 (8.70%) 
Lymphedema * 1  1/7 (14.29%)  0/7 (0.00%)  0/2 (0.00%)  0/45 (0.00%)  0/46 (0.00%) 
1
Term from vocabulary, NCI CTCAE 4.0
*
Indicates events were collected by non-systematic assessment
Experimental Arm C (VR-CHOP) was discontinued early in phase I due to low accrual; only 2 participants received VR-CHOP.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: AMC Statistical Center
Organization: AIDS Malignancy Consortium
Phone: 501-526-6712
EMail: jylee@uams.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01193842     History of Changes
Other Study ID Numbers: NCI-2011-02508
NCI-2011-02508 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000683379
AMC #75
AMC-075 ( Other Identifier: AIDS Malignancy Consortium )
AMC-075 ( Other Identifier: DCP )
AMC-075 ( Other Identifier: CTEP )
UM1CA121947 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2010
First Posted: September 2, 2010
Results First Submitted: February 23, 2018
Results First Posted: June 12, 2018
Last Update Posted: October 29, 2019