Trial Outcomes & Findings for A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma (NCT NCT01460940)

NCT ID: NCT01460940

Last Updated: 2017-11-14

Results Overview

Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: up to 24 months
• Results posted on: 2017-11-14

Participant Flow

Participant milestones

Measure	Lenalidomide and Panobinostat In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Lenalidomide and Panobinostat n=24 Participants In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.

Outcome measures

Measure

Lenalidomide and Panobinostat n=24 Participants In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.

Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)

16.7 percentage of patients

SECONDARY outcome

Timeframe: up to 24 months

Population: Grade 3-4 toxicities

Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0

Outcome measures

Measure	Lenalidomide and Panobinostat n=24 Participants In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma. neutropenia	58.3 percentage of patients
Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma. thrombocytopenia	41.7 percentage of patients
Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma. febrile neutropenia	25.0 percentage of patients
Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma. hypophosphatemia	25.0 percentage of patients

SECONDARY outcome

Timeframe: 3-5 years

Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive

Outcome measures

Measure

Lenalidomide and Panobinostat n=24 Participants In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.

Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat

3.8 months Interval 1.8 to 5.9

Adverse Events

Lenalidomide and Panobinostat

Serious events: 17 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lenalidomide and Panobinostat n=24 participants at risk In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
Blood and lymphatic system disorders Thrombocytopenia	4.2% 1/24 • Number of events 1
Blood and lymphatic system disorders Neutropenia	12.5% 3/24 • Number of events 3
Investigations Fatigue	4.2% 1/24 • Number of events 1
Infections and infestations Febrile Neutropenia	16.7% 4/24 • Number of events 4
Infections and infestations Infection without Neutropenia	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Hyponatremia	4.2% 1/24 • Number of events 1
Gastrointestinal disorders Dehydration	4.2% 1/24 • Number of events 1
Psychiatric disorders Altered Mental Status	4.2% 1/24 • Number of events 1
Metabolism and nutrition disorders Hyperbilirubinemia/Transaminitis	4.2% 1/24 • Number of events 1
Gastrointestinal disorders Nausea/vomiting	4.2% 1/24 • Number of events 1
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1

Other adverse events

Measure	Lenalidomide and Panobinostat n=24 participants at risk In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design. panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days. lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
Infections and infestations Neutropenia	45.8% 11/24 • Number of events 11
Investigations Lymphopenia	25.0% 6/24 • Number of events 6
Blood and lymphatic system disorders Febrile Neutropenia	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Hypokalemia	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Hypophosphatemia	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Hyperbilirubinemia/Transaminitis	8.3% 2/24 • Number of events 2
Blood and lymphatic system disorders Thrombocytopenia	37.5% 9/24 • Number of events 9
Infections and infestations Infection without Neutropenia	8.3% 2/24 • Number of events 2

Additional Information

Dr. Kristie Blum

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-4590

Email: Kristie.Blum@osumc.edu

Results disclosure agreements

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