Mantle Cell LymphomaPhase 1/2NCT03523975
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
A Phase 1/2 study testing Venetoclax, Lenalidomide and Rituximab in people with Mantle Cell Lymphoma, run by City of Hope Medical Center at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Venetoclax, Lenalidomide and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Dec 2018to 24 Jun 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Dahlia Sano, 734-764-8195, dsano@med.umich.edu
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Craig Portell, MD, 434-924-9637, CP4YS@uvahealth.org
Craig Portell, MD
- Not yet recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Ohio State Comprehensive Cancer Center, 800-293-5066, OSUCCCClinicaltrials@osumc.edu
David Bond, MD, 614-293-3196, David.Bond@osumc.edu
- Recruiting
City of Hope Medical center
Duarte, California, 91010
Tycel Phillips, MD, 6263598111, tphillips@coh.org
Tycel Phillips, M.D.
About this study
Official title: Phase I/II Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
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).
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Venetoclax, Lenalidomide, Rituximab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
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.
LenalidomideDrug
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.
RituximabDrug
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 group | Role | What they receive |
|---|---|---|
| Venetoclax, Lenalidomide, Rituximab | Experimental | 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. Receives: Drug: Venetoclax; Drug: Lenalidomide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Measured: 42 Days
Secondary outcomes (2)
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
Measured: Up to 4 Years
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
Measured: Up to 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start28 Dec 2018
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tycel Phillips, M.D., Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523975
- Sponsor's protocol ID
- 19335
- Other IDs
- HUM00140979
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2018
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Phillips TJ, Bond D, Takiar R, Kump K, Kandarpa M, Boonstra P, Mayer TL, Nachar V, Wilcox RA, Carty SA, Karimi YH, Nikolovska-Coleska Z, Kaminski MS, Herrera AF, Maddocks K, Popplewell L, Danilov AV. Adding venetoclax to lenalidomide and rituximab is safe and effective in patients with untreated mantle cell lymphoma. Blood Adv. 2023 Aug 22;7(16):4518-4527. doi: 10.1182/bloodadvances.2023009992.
PubMed 37013954