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

Primary Purpose

Mantle Cell Lymphoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Venetoclax
Lenalidomide
Rituximab
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/tablets

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.

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • University of Michgan Comprehensive Cancer Center
  • The Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetoclax, Lenalidomide, Rituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab

Secondary Outcome Measures

The proportion of patients with a Complete Response (CR)
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
The proportion of patients that respond to treatment
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

Full Information

First Posted
April 26, 2018
Last Updated
October 18, 2022
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03523975
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax, Lenalidomide, Rituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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 Measure Information:
Title
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
The proportion of patients with a Complete Response (CR)
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
Time Frame
Up to 4 Years
Title
The proportion of patients that respond to treatment
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
Time Frame
Up to 4 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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/tablets 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Wilcox, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Michgan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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