Trial Outcomes & Findings for Oral Panobinostat Adult Patients DLBCL Relapsed/Refractory Stem Cell Transfusion (ASCT) or Not Eligible for ASCT (NCT NCT01523834)

NCT ID: NCT01523834

Last Updated: 2019-11-22

Results Overview

ORR is defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to the Cheson 1999 response criteria

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-11-22

Participant Flow

Date of first enrolment: 14th June 2011 Date of last completed: 3rd April 2017 All patients (35) were enrolled in Italy.

Participant milestones

Measure	Panobinosat The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment:Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle. Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio
Overall Study STARTED	35
Overall Study Consolidation Phase	7
Overall Study Maintenance Phase	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Panobinostat Adult Patients DLBCL Relapsed/Refractory Stem Cell Transfusion (ASCT) or Not Eligible for ASCT

Baseline characteristics by cohort

Measure	Panobinosat n=35 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW), as part of a 4 week (28 days) treatment cycle. Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle.
Age, Continuous	73 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment Italy	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT.

ORR is defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to the Cheson 1999 response criteria

Outcome measures

Measure

Panobinosat n=35 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio

Overall Response Rate (ORR) at the End of the Induction Phase

17.1 percentage of participants Interval 6.6 to 33.6

SECONDARY outcome

Timeframe: 6 months

Population: Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT

Proportion of CR at the end of the induction phase according to the Cheson 1999 response criteria

Outcome measures

Measure

Panobinosat n=35 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio

Complete Response (CR) Rate

11.4 percentage of participants Interval 3.2 to 26.7

SECONDARY outcome

Timeframe: 36 months

Population: Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT

TTR is defined as the time from enrolment to Overall Response

Outcome measures

Measure

Panobinosat n=9 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio

Time to Response (TTR)

2.6 months Interval 1.8 to 12.0

SECONDARY outcome

Timeframe: 36 months

Population: Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT

PFS is defined as the time from enrolment to disease progression or relapse or death from any cause

Outcome measures

Measure

Panobinosat n=35 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio

Progression Free Survival (PFS)

2.4 months Interval 1.4 to 7.0

SECONDARY outcome

Timeframe: 36 months

Population: Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT

OS is defined as the time from enrolment to death from any case

Outcome measures

Measure

Panobinosat n=35 Participants The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio

Overall Survival (OS)

7.6 months Interval 3.0 to 12.7

Adverse Events

Panobinosat

Serious events: 12 serious events

Other events: 8 other events

Deaths: 29 deaths

Serious adverse events

Measure	Panobinosat n=35 participants at risk The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted.
Renal and urinary disorders Urinary tract pain	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Renal and urinary disorders Acute renal injury	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Cardiac disorders Parossistic atrial fibrillation and congestive heart failure	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Cardiac disorders Chest Pain	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Cardiac disorders Arrhythmia	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Gastrointestinal disorders Subocclusive syndrome	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Infections and infestations Pneumonia	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Metabolism and nutrition disorders Nausea, vomit, diarrea, ipoK+, atc prolonged	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Nervous system disorders Paralysis of arms	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Vascular disorders Deep vein thrombosis	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Vascular disorders Aortic aneurysm rupture	2.9% 1/35 • Number of events 1 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.

Other adverse events

Measure

Panobinosat n=35 participants at risk The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted.

General disorders Disease progression

22.9% 8/35 • Number of events 8 • 6 years We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.

Additional Information

Dr. Francesco Zaja, Co-Investigator of the Study

Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - SOC Clinica Ematologica

Phone: +39 0432559604

Email: francesco.zaja@asuiud.sanita.fvg.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place