Trial Outcomes & Findings for Oral LBH589 in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) (NCT NCT01090973)

NCT ID: NCT01090973

Last Updated: 2013-12-16

Results Overview

Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed \<50% of normal daytime; 3 Needs to be in bed \>50% of normal daytime; 4 Unable to get out of bed.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response
• Results posted on: 2013-12-16

Participant Flow

Participant milestones

Measure	Oral Drug Treatment LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Oral Drug Treatment LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Overall Study Disease progression	1

Baseline Characteristics

Oral LBH589 in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

Baseline characteristics by cohort

Measure	Oral Drug Treatment n=1 Participants LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.

Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to determine the duration of responses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to estimate the progression free survival time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Investigators intended to monitor the QTc interval in patients receiving oral LBH589

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks (2 cycles) unless treatment continues due to partial or complete response

Population: The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent. The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.

Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf.

Outcome measures

Measure	Oral Drug Treatment n=1 Participants LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Number of Participants With Adverse Events (AEs)	1 participants

Adverse Events

Oral Drug Treatment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Drug Treatment n=1 participants at risk LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Blood and lymphatic system disorders Death not associated with CTCAE term - Disease progression NOS	100.0% 1/1 • Number of events 1 • 46 days

Other adverse events

Measure	Oral Drug Treatment n=1 participants at risk LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Gastrointestinal disorders Hemorrhage, GI - Upper GI NOS	100.0% 1/1 • Number of events 1 • 46 days

Additional Information

Celeste Bello, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8623

Email: celeste.bello@moffitt.org

Results disclosure agreements

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