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New treatment option for Mantle Cell Lymphoma
Official title Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT03523975
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Ann Arbor, Michigan, United States
- Columbus, Ohio, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Ann Arbor, Michigan, United States; Columbus, Ohio, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.