Trial Outcomes & Findings for Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT00667615)
NCT ID: NCT00667615
Last Updated: 2018-01-05
Results Overview
Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in \>= 50% of participants
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2018-01-05
Participant Flow
Participant milestones
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
n=30 Participants
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
Age, Continuous
|
76 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearMaximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in \>= 50% of participants
Outcome measures
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
n=30 Participants
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
|
300 mg/m2
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
n=30 Participants
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.
|
32 percentage of participants with CR
|
Adverse Events
Relapsed or Refractory Diffuse Large B-cell Lymphoma
Serious events: 19 serious events
Other events: 30 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
n=30 participants at risk
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • 5 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.3%
1/30 • 5 years
|
|
Cardiac disorders
Cardiac Arrhythmia, other
|
3.3%
1/30 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • 5 years
|
|
Investigations
Creatinine
|
3.3%
1/30 • 5 years
|
|
General disorders
Death NOS
|
13.3%
4/30 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
4/30 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • 5 years
|
|
General disorders
Fatigue
|
13.3%
4/30 • 5 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
20.0%
6/30 • 5 years
|
|
General disorders
Fever
|
6.7%
2/30 • 5 years
|
|
Investigations
Hemoglobin
|
16.7%
5/30 • 5 years
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
3.3%
1/30 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.3%
1/30 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • 5 years
|
|
Infections and infestations
Infection - lung (pneumonia)
|
6.7%
2/30 • 5 years
|
|
Infections and infestations
Infection - other
|
3.3%
1/30 • 5 years
|
|
Investigations
White blood cell
|
13.3%
4/30 • 5 years
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • 5 years
|
|
Gastrointestinal disorders
Mucositis (func/sympt)- Stomach
|
3.3%
1/30 • 5 years
|
|
Nervous system disorders
Neurology - other
|
3.3%
1/30 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
6.7%
2/30 • 5 years
|
|
Investigations
Platelets
|
20.0%
6/30 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • 5 years
|
|
Nervous system disorders
Syncope
|
6.7%
2/30 • 5 years
|
|
Vascular disorders
Thrombosis
|
3.3%
1/30 • 5 years
|
Other adverse events
| Measure |
Relapsed or Refractory Diffuse Large B-cell Lymphoma
n=30 participants at risk
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
|
|---|---|
|
General disorders
Fatigue
|
43.3%
13/30 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
43.3%
13/30 • 5 years
|
|
Investigations
White blood cells
|
43.3%
13/30 • 5 years
|
|
Investigations
Platelets
|
40.0%
12/30 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.7%
11/30 • 5 years
|
|
Investigations
Lymphocytes
|
36.7%
11/30 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
10/30 • 5 years
|
|
Investigations
Neutrophils
|
30.0%
9/30 • 5 years
|
|
Investigations
AST
|
23.3%
7/30 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
7/30 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
7/30 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
7/30 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
7/30 • 5 years
|
|
Investigations
ALT
|
20.0%
6/30 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
6/30 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • 5 years
|
|
Investigations
INR
|
20.0%
6/30 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
6/30 • 5 years
|
|
General disorders
Constitutional Symptoms, other
|
16.7%
5/30 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
5/30 • 5 years
|
|
General disorders
Pain
|
16.7%
5/30 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
5/30 • 5 years
|
|
Investigations
Alkaline phosphatase
|
13.3%
4/30 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.3%
4/30 • 5 years
|
|
General disorders
Hemorrhage
|
13.3%
4/30 • 5 years
|
|
Infections and infestations
Infection, other
|
13.3%
4/30 • 5 years
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • 5 years
|
|
Gastrointestinal disorders
Pain - throat
|
13.3%
4/30 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
4/30 • 5 years
|
|
Nervous system disorders
Dysarthria
|
13.3%
4/30 • 5 years
|
|
Investigations
Hyperbilirubinemia
|
10.0%
3/30 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • 5 years
|
|
General disorders
Edema - limb
|
10.0%
3/30 • 5 years
|
|
General disorders
Fever
|
10.0%
3/30 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
10.0%
3/30 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
3/30 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
3/30 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place