Trial Outcomes & Findings for PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (NCT NCT00303953)
NCT ID: NCT00303953
Last Updated: 2014-05-12
Results Overview
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
assessed at week 8, and every 3 months for 3 years
Results posted on
2014-05-12
Participant Flow
Participant milestones
| Measure |
PXD101
Only eligible patients were included in the analyses. Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
Eligible
|
21
|
|
Overall Study
Eligible and Treated
|
20
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
PXD101
Only eligible patients were included in the analyses. Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
PXD101
n=20 Participants
Only eligible patients were included in the analyses. Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Age, Continuous
|
68.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at week 8, and every 3 months for 3 yearsPopulation: All eligible patients who started treatment were included in assessing response estimates.
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome measures
| Measure |
PXD101
n=20 Participants
Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response (CR)
|
0 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response Unconfirmed (CRU)
|
0 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Partial Response (PR)
|
0 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
No response
|
20 participants
|
SECONDARY outcome
Timeframe: assessed every 3 months for 3 yearsPopulation: Only eligible patients were included in the analyses.
Measured from time of registration to death, or last contact date
Outcome measures
| Measure |
PXD101
n=20 Participants
Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Overall Survival
|
0.9 years
Interval 0.2 to 2.3
|
SECONDARY outcome
Timeframe: assessed at week 8, then every 3 months for 3 yearsPopulation: Only eligible patients were included in the analyses.
Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
Outcome measures
| Measure |
PXD101
n=20 Participants
Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Progression-free Survival
|
0.2 years
Interval 0.1 to 0.3
|
Adverse Events
PXD101
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PXD101
n=20 participants at risk
Only eligible patients were included in the analyses. Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Platelets
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
Other adverse events
| Measure |
PXD101
n=20 participants at risk
Only eligible patients were included in the analyses. Patients receive 1000 mg/m\^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
35.0%
7/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
20.0%
4/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
General disorders
Edema: limb
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
8/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
General disorders
Injection site reaction/extravasation changes
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
25.0%
5/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
30.0%
6/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Alkaline phosphatase
|
20.0%
4/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Cholesterol, serum-high (hypercholesterolemia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Creatinine
|
20.0%
4/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Leukocytes (total WBC)
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Lymphopenia
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Platelets
|
25.0%
5/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Investigations
Prolonged QTc interval
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Nervous system disorders
Neurology-Other (Specify)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Nervous system disorders
Neuropathy: sensory
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Hot flashes/flushes
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
10.0%
2/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
|
Vascular disorders
Vascular-Other (Specify)
|
5.0%
1/20 • After every cycle while on protocol treatment, for a maximum of 2 years
|
Additional Information
Lymphoma Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60