Trial Outcomes & Findings for Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma (NCT NCT01169636)
NCT ID: NCT01169636
Last Updated: 2021-01-06
Results Overview
Maximum Tolerated Dose (MTD) of Panobinostat + ICE
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
From first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose, up to 6 years
Results posted on
2021-01-06
Participant Flow
Recruitment period: January 2011 to March 2016
62 participants enrolled, 3 participants not treated on the study (1) adverse event (1) financial issue, and (1) consent withdrawal.
Participant milestones
| Measure |
Phase I: Panobinostat + ICE 10 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 20 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 30 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II: Panobinostat + ICE
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
20
|
13
|
14
|
|
Overall Study
COMPLETED
|
3
|
6
|
17
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
1
|
3
|
Reasons for withdrawal
| Measure |
Phase I: Panobinostat + ICE 10 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 20 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 30 mg
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II: Panobinostat + ICE
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Screen failure
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I: Panobinostat + ICE 10 mg
n=3 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 20 mg
n=6 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 30 mg
n=20 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
n=12 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II: Panobinostat + ICE
n=11 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose, up to 6 yearsMaximum Tolerated Dose (MTD) of Panobinostat + ICE
Outcome measures
| Measure |
Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD)
n=29 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II Panobinostat + ICE
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Panobinostat + ICE
|
30 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed after 3 cycles of ICE (2 months)Population: Per protocol all Phase I Cohorts are analyzed as a single group.
Will be assessed by Kaplan-Meier methods.
Outcome measures
| Measure |
Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD)
n=29 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
n=12 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II Panobinostat + ICE
n=11 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|
|
Number of Participants With Complete Remission (CR)
Progressive Disease
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Complete Remission (CR)
Complete Response
|
21 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With Complete Remission (CR)
Partial Response
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Complete Remission (CR)
Stable Disease
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 16 monthsPopulation: Per protocol all Phase I Cohorts are analyzed as a single group.
FFS duration was calculated from date of study entry to date of progression or death or change of therapy, whichever came first.
Outcome measures
| Measure |
Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD)
n=29 Participants
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
n=12 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II Panobinostat + ICE
n=11 Participants
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|
|
Percentage of Participants With Failure Free Survival (FFS)
|
61 percentage of participants
|
82 percentage of participants
|
75 percentage of participants
|
Adverse Events
Phase I: Panobinostat + ICE 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I: Panobinostat + ICE 20 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I: Panobinostat + ICE 30 mg
Serious events: 20 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase II: Standard of Care (ICE)
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase II: Panobinostat+ICE
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Panobinostat + ICE 10 mg
n=3 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 20 mg
n=6 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 30 mg
n=20 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
n=12 participants at risk
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II: Panobinostat+ICE
n=11 participants at risk
Participants are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|---|---|
|
Investigations
Neutropenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
55.0%
11/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
63.6%
7/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
55.0%
11/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
95.0%
19/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
75.0%
9/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
11/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
55.0%
11/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
50.0%
6/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
11/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
15.0%
3/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Dizziness
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Fatigue
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
36.4%
4/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
2/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
Other adverse events
| Measure |
Phase I: Panobinostat + ICE 10 mg
n=3 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 20 mg
n=6 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase I: Panobinostat + ICE 30 mg
n=20 participants at risk
The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
|
Phase II: Standard of Care (ICE)
n=12 participants at risk
Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
Phase II: Panobinostat+ICE
n=11 participants at risk
Participants are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
95.0%
19/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
12/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
81.8%
9/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
15.0%
3/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
55.0%
11/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
75.0%
9/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
63.6%
7/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
50.0%
10/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
63.6%
7/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
10.0%
2/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
2/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
45.5%
5/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Investigations
Neutropenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
95.0%
19/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
41.7%
5/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
72.7%
8/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
60.0%
12/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Investigations
Thrombocytopenia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
95.0%
19/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
91.7%
11/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
11/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
95.0%
19/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
83.3%
10/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
11/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Investigations
AST
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
20.0%
4/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Investigations
ALT
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
30.0%
6/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
2/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
30.0%
6/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
33.3%
4/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
45.5%
5/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
30.0%
6/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
35.0%
7/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
41.7%
5/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
36.4%
4/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
3/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Dizziness
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
25.0%
5/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Fatigue
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
90.0%
18/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
100.0%
12/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
90.9%
10/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Dehydration
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
5.0%
1/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
2/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
0.00%
0/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
2/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
18.2%
2/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
16.7%
1/6 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
10.0%
2/20 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
8.3%
1/12 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
9.1%
1/11 • All AE were recorded from first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose.
|
Additional Information
Dr. Christopher Flowers, MD/ Chair, Chair, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: 713-745-6095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place