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

Mass General Brigham

Status and phase: Terminated; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Panobinostat with Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01282476

10-441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Panobinostat/Rituximab

Experimental group

Description:

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.

Treatment:

Drug: Panobinostat with Rituximab