Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Phase 2

Terminated

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Panobinostat with Rituximab

• Registration Number: NCT01282476
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory studies. However, it is not known if it will show the same activity in humans. Panobinostat has been given to participants with various types of cancers, including DLBCL, in previous research studies. In this study panobinostat will be given with the the antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.

Detailed Description

Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.

If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.

Study Timeline

• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-06
• Primary Completion: 2013-08
• Study Completion: 2014-08
• Results First Submitted: 2017-02-14
• Results First Submitted QC: 2017-02-14
• Results First Posted: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Relapsed or refractory DLBCL
• More than 1 line of prior chemotherapy

Exclusion Criteria

• Currently receiving anticancer therapy or investigational agents
• Major surgery within last 4 weeks
• Known leptomeningeal or brain metastases
• Known HIV infection
• Uncontrolled fungal, bacterial, viral or other infection
• History of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 3 years
• Hepatitis B or C positive
• GI disease
• Pregnant or breastfeeding
• Prior treatment with an HDAC inhibitor including valproic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Panobinostat/Rituximab	Panobinostat with Rituximab	single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	1 year	Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).; Overall response (OR) = Complete response (CR) + Partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Toxicities	1 year	Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening
Progression-free Survival Rate	6 months	Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States