Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large B Cell Lymphoma |
Drug: Panobinostat with Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma |
- Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Progression-free survival and duration of response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Evaluate safety of this combination in relapsed/refractory DLBCL patients [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evaluate the impact of baseline expression of BCL6 and pAKT on response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panobinostat/Rituximab |
Drug: 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.
Other Names:
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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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Christine Connolly | 617-726-5131 | cconnolly1@partners.org |
| Contact: Jeremy Abramson, MD | 617-726-8743 | jabramson@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Principal Investigator: Jeremy S Abramson, MD | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: David C Fisher, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Robin Joyce, MD | |
| Principal Investigator: | Jeremy S Abramson, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01282476 History of Changes |
| Other Study ID Numbers: | 10-441 |
| Study First Received: | January 21, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
DLBCL Panobinostat LBH589 LBH-589 |
HDAC inhibitor DAC inhibitor deacetylase inhibitor lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013