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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Panobinostat with Rituximab
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring DLBCL (Diffuse Large B Cell Lymphoma), Panobinostat, LBH589 (Panobinostat), LBH-589 (Panobinostat), HDAC inhibitor (Histone deacetylase inhibitor), DAC inhibitor (deacetylase inhibitor), deacetylase inhibitor, lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panobinostat/Rituximab

Arm 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.

Outcomes

Primary Outcome Measures

Overall Response Rate
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

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

Full Information

First Posted
January 21, 2011
Last Updated
April 3, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01282476
Brief Title
Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Official Title
Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
June 2011 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
DLBCL (Diffuse Large B Cell Lymphoma), Panobinostat, LBH589 (Panobinostat), LBH-589 (Panobinostat), HDAC inhibitor (Histone deacetylase inhibitor), DAC inhibitor (deacetylase inhibitor), deacetylase inhibitor, lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panobinostat/Rituximab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Panobinostat with Rituximab
Other Intervention Name(s)
LBH589, LBH-569, Rituxan
Intervention Description
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 Measure Information:
Title
Overall Response Rate
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free Survival Rate
Description
Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
Time Frame
6 months
Title
Toxicities
Description
Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy S Abramson, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17242396
Citation
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
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Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

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