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A Phase 2 Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma

Clinical Trial Details

This clinical trial is open to women and men age 18 and older with previously treated mantle cell lymphoma (MCL). Mantle Cell Lymphoma (MCL) is a distinct B-cell lymphoma that represents 5-10% of all non-Hodgkin lymphomas (NHL), often follows an aggressive clinical course, and is considered incurable with standard chemoimmunotherapy. 

While there are several therapeutic options available for MCL patients at relapse, none of them have long-lasting response durations. Also, the ability to improve outcomes with effective therapies while minimizing and managing toxicities can be difficult. The pre-clinical rationale, in addition to the early results of the phase 1 combination trial, suggest that this combination will provide a greater depth and duration of response than that seen with single agent ibrutinib therapy. 

The primary objective of this study is to evaluate the efficacy of palbociclib in combination with ibrutinib in terms of progression-free survival (PFS) to therapy in patients with previously treated mantle cell lymphoma. 

Brief study summary: 

  • Length of time on treatment will vary depending on response of treatment- a cycle is 28 days. Length of follow-up is 2 years after removal from study. 
  • Treatment will consist of palbociclib administered with food at 100 mg oral once daily for 21 days followed by 7 days off and ibrutinib administered at 560 mg oral continuously. 
  • Subject will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects 

    

Key Eligibility: 
  • Women and men age 18 and older
  • Diagnosis of mantle cell lymphoma (MCL) who have received at least one prior systemic therapy 
  • Detailed eligibility reviewed when you contact the study team 

    

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN, NP
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1712018829

ClinicalTrials.gov:

NCT02159755

Status

Open to Enrollment

Age Group

Adult

Sponsor