Clinical Trial: Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B Cell Lymphoma

Brief Summary: A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B cell Lymphoma

Detailed Summary:

Primary:

To determine the maximum tolerated dose and toxicity of the combination of oral ixazomib and lenalidomide plus rituximab in patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5

Secondary:

  • To determine overall response rate in an expanded cohort at the MTD for follicular lymphoma and for non-follicular low-grade B cell lymphoma
  • Duration of response, time to progression, progression free survival, time to treatment failure and overall survival
  • Create tissue microarray from paraffin embedded tissue for future studies.
  • Assessment of baseline lymphocyte subsets as prognostic markers.
  • Assessment of blood flow cytometric evaluation of minimal residual disease post-treatment correlation with PFS

Overview of Study Design:

This study combines three classes of agents that have non-overlapping mechanisms of action and toxicity profiles, with each pair having demonstrated clinical evidence of benefit without unexpected toxicity. We use the lenalidomide-rituximab backbone, feasible and active in lymphoma, and add a novel oral proteasome inhibitor to potentially enhance efficacy, minimize toxicity and limit patient visits for treatment.

Patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5 will be treated with the combination of oral ixazomib + lenalidomide + rituximab.

The primary obj
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: maximum tolerated dose of oral ixazomib [ Time Frame: Up to 15 months after beginning treatment ]

To determine the maximum tolerated dose and toxicity of the combination of oral ixazomib and lenalidomide plus rituximab in patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate [ Time Frame: Up to 15 months after beginning treatment ]
    These criteria are based on the Revised Response Criteria for Malignant Lymphoma and include the following categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Relapse and Progression (PD).
  • Duration of response [ Time Frame: Up to 15 months after beginning treatment ]

    Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.

  • Time to progression [ Time Frame: Up to 15 months after beginning treatment ]
    Duration of time from start of treatment to time of progression.
  • Progression free survival [ Time Frame: Up to 15 months after beginning treatment ]
    progression free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
  • Time to treatment failure [ Time Frame: Up to 15 months after beginning treatment ]
    Time to treatment failure (event-free survival) is defined as the time from study entry to first event of disease progression, discontinuation of treatment for any reason, initiation of new treatment, or death.
  • Overall survival [ Time Frame: Up to 15 months after beginning treatment ]
    Overall survival is defined as the date of study entry to the date of death.


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: September 8, 2016
Date Started: September 2016
Date Completion: June 2024
Last Updated: September 12, 2016
Last Verified: September 2016