Clinical Trials /

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

NCT03523975

Description:

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Suspended

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
  • Official Title: Phase I Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2018.005
  • SECONDARY ID: HUM00140979
  • NCT ID: NCT03523975

Conditions

  • Mantle Cell Lymphoma

Interventions

DrugSynonymsArms
VenetoclaxVenetoclax, Lenalidomide, Rituximab
LenalidomideVenetoclax, Lenalidomide, Rituximab
RituximabVenetoclax, Lenalidomide, Rituximab

Purpose

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).

Trial Arms

NameTypeDescriptionInterventions
Venetoclax, Lenalidomide, RituximabExperimentalRituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
  • Venetoclax
  • Lenalidomide
  • Rituximab

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years

          -  Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment

          -  Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL

          -  ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an
             attempt to quantify cancer patients' general well-being and activities of daily life.
             The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to
             2

          -  All study participants must be registered into the mandatory Revlimid REMS® program,
             and be willing and able to comply with the requirements of the REMS® program

          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as
             required in the Revlimid REMS® program.

          -  Men and Women of childbearing potential on appropriate contraception

          -  Adequate organ function

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Ability to swallow oral capsules/tables

        Exclusion Criteria:

          -  Prior treatment for MCL with chemotherapy

          -  Pregnant or breastfeeding women

          -  Grade 2 or higher peripheral neuropathy

          -  Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study
             enrollment

          -  Significant cardiovascular disease

          -  Any condition that might significantly impair drug absorption as determined by the
             investigator

          -  Uncontrolled active systemic fungal, bacterial, viral, or other infection, or
             intravenous anti-infective treatment within 2 weeks before first dose of study drug

          -  History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug

          -  Concurrent participation in another clinical trial

          -  Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week
             prior to treatment initiation.

          -  Psychiatric illness or social situations that would limit compliance with study
             requirements

          -  Subject has known positivity to HIV

          -  Active infection with Hepatitis B or C virus as determined by a detectable viral load
             on PCR.

          -  Prior malignancy except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or any other cancer from which the subject has been
             disease free for ≥ 2 years or which will not limit survival to< 2 years.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Time Frame:42 Days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The proportion of patients with a Complete Response (CR)
Time Frame:Up to 4 Years
Safety Issue:
Description:Response will be assessed by the IRC (Immune-related Response Criteria) and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening
Measure:The proportion of patients that respond to treatment
Time Frame:Up to 4 Years
Safety Issue:
Description:The proportion of patients who achieve either partial or complete response by PET, CT and marrow. Response will be assessed by the IRC and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Rogel Cancer Center

Last Updated

February 6, 2019