A Phase I Study of Panobinostat in Combination With Bortezomib in the Treatment of Relapsed and/or Refractory Mantle Cell Lymphoma

Anand Jillella1 site in 1 country3 target enrollmentApril 2011

ConditionsMantle Cell Lymphoma

InterventionsPanobinostat Bortezomib

DrugsPanobinostat Bortezomib

Overview

Phase: Phase 1
Intervention: Panobinostat
Conditions: Mantle Cell Lymphoma
Sponsor: Anand Jillella
Enrollment: 3
Locations: 1
Primary Endpoint: Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and clinical efficacy of the combination of panobinostat plus bortezomib.

Detailed Description

This is a phase I single arm, open label, multi-center (3 participating sites) dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV) infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat. There will be sub-investigators participating in this study who will enroll at sub-sites.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Anand Jillella

Responsible Party

Sponsor Investigator

Principal Investigator

Anand Jillella

Chief, Hematology/Oncology

Augusta University

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged ≥ 18 years old
•Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
•Patients must have adequate hematology/chemistry lab values
•Echocardiogram (ECHO) must demonstrate Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
•Patients with previously diagnosed MCL based on standard criteria and with at least one and a maximum of 4 lines of therapy and currently requiring further treatment
•Prior therapy with autologous and allogeneic stem cell transplant is permissible. Patients who have undergone an allogeneic transplant should have no evidence of graft-versus-host disease (GVHD) and should not be on any immunosuppressive therapy. Autologous and allogeneic transplant will be counted as one prior therapy.
•Patients previously treated with bortezomib will be included in the study

Exclusion Criteria

•Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
•Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 (Panobinostat) treatment
•Peripheral neuropathy ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) grade 2 on clinical examination within 14 days of randomization
•Impaired cardiac function or clinically significant cardiac diseases
•Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LBH589
•Patients with diarrhea \> CTCAE grade
•Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
•Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
•Patients who have received targeted agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies.
•Patients who have received either immunotherapy within \< 8 weeks; chemotherapy within \< 4 weeks; or radiation therapy to \> 30% of marrow-bearing bone within \< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies.