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Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B Cell Lymphoma

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Trial Information

Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma


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 will be
done weekly in Cycle 1 and then once in each cycle. PET/CT 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jeremy S Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

10-441

NCT ID:

NCT01282476

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Diffuse Large B Cell Lymphoma
  • DLBCL
  • Panobinostat
  • LBH589
  • LBH-589
  • HDAC inhibitor
  • DAC inhibitor
  • deacetylase inhibitor
  • lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617