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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03523975
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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.
  • Lenalidomide — DRUG
    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.
  • Rituximab — DRUG
    375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12

Study Details

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).

Key Dates

Start date
Dec 24, 2018
Status verified
Apr 2026
Primary completion
Jun 24, 2027
Completion
Jun 24, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Medical centerDuarteCalifornia91010
Tycel Phillips, MD
[email protected]
6263598111
Tycel Phillips, M.D. (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Dahlia Sano
[email protected]
734-764-8195
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Ohio State Comprehensive Cancer Center
[email protected]
800-293-5066
David Bond, MD
[email protected]
614-293-3196
David S Bond, M.D. (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22903
Craig Portell, MD
[email protected]
434-924-9637
Craig Portell, MD (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical center· Duarte, CAUniversity of Michigan· Ann Arbor, MIThe Ohio State University Comprehensive Cancer Center· Columbus, OHUniversity of Virginia Cancer Center· Charlottesville, VA

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