Phase I Study of Panobinostat + Bortezomib for Relapsed and/or Refractory Mantle Cell Lymphoma (MCL)
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 24
Summary
- Conditions
- Mantle Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT01504776
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- Principal Investigator: Anand Jillella, MD Augusta University
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