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Trial record 16 of 128 for:    Venetoclax AND complete response

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

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ClinicalTrials.gov Identifier: NCT03523975
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Venetoclax Drug: Lenalidomide Drug: Rituximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Venetoclax, Lenalidomide, Rituximab
Rituximab 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.
Drug: 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.

Drug: 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.

Drug: Rituximab
375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab [ Time Frame: 42 Days ]

Secondary Outcome Measures :
  1. The proportion of patients with a Complete Response (CR) [ Time Frame: Up to 4 Years ]
    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

  2. The proportion of patients that respond to treatment [ Time Frame: Up to 4 Years ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523975


Contacts
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Contact: Tycel Phillips, MD 734-232-2883 tycelp@med.umich.edu

Locations
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United States, Michigan
University of Michgan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48187
Contact: Tycel Phillips, M.D.    734-232-2883    tycelp@umich.edu   
Principal Investigator: Tycel Phillips, M.D.         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Tycel Phillips, MD University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03523975     History of Changes
Other Study ID Numbers: UMCC 2018.005
HUM00140979 ( Other Identifier: University of Michigan )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Venetoclax
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors