New cocktail targets tough lymphoma
NCT ID NCT02446236
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This early-phase study tests a combination of three drugs (ibrutinib, lenalidomide, and rituximab) in people with mantle cell lymphoma that has returned or not responded to prior treatment. The main goal is to find the safest dose of this combination by monitoring side effects. Up to 27 adults will participate, and treatment continues until the disease worsens or side effects become unacceptable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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27 people
The number who actually took part.
- Started
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Jun 2015
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age greater than or equal to 18 years. * Histologically or cytologically confirmed diagnosis of MCL. * Relapsed or refractory MCL patients who have received at least one prior therapy are eligible. Patients who have previously received high-dose chemotherapy with peripheral stem cell support are eligible. * Presence of at least one lymph node evaluable or mass measurable for response. * Eastern Cooperative Oncology Group Performance Status greater than 2. * Platelets \> 75,000/μL and absolute neutrophils count (ANC) \> 1,000/μL within 14 days of study registration (unless the treating physician deems the neutropenia is related to bone marrow involvement, then an ANC of \> 750/mm 3 is allowed) * Normal renal function defined as serum creatinine less than 2. * Recovery from any previous treatment therapy. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test * 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. * Ability to understand, and willingness to sign, a written informed consent document. * Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients intolerant to ASA may use low molecular weight heparin). * Normal organ and bone marrow function parameter: Laboratory tests Required value WBC \>3000/μL\* Absolute neutrophils count \>1,000/μL\* Platelets \>75,000/μL Total bilirubin \< 1.5Within normal institutional limits AST (SGOT) and ALT (SGPT) \<3 x institutional upper limit of normal Creatinine or creatinine clearance \<1.5 within normal institutional limits \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated by Cockcroft-Gault formula) Exclusion Criteria: * Concomitant use of warfarin or other Vit K antagonists * Central nervous system (CNS) involvement by lymphoma at time of enrollment. * Other medical conditions that would potentially interfere with patient participation in this trial. * A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix (unless for other tumor type patient was treated with curative intent at least 2 years previously.) * Known human immunodeficiency virus (HIV-1) infection or chronic hepatitis B, or C (Hep B serology positive without active infection will be eligible) * Active, clinically serious infection \> CTCAE grade 2. Patients may be eligible upon resolution of the infection. * Major surgery or significant traumatic injury within 28 days of the first dose of study drug. * Use of any other standard chemotherapy, radiation therapy, or experimental drug therapy for the treatment of MCL within 21 days of starting treatment or 5 half life times (whatever is shorter) * Patients with grade 3/4 cardiac problems, as defined by the New York Heart Association (NYHA) criteria: * History of uncontrolled or symptomatic angina * History of uncontrolled arrhythmias * Myocardial infarction \< 6 months from study entry * Uncontrolled or symptomatic congestive heart failure * Ejection fraction below the institutional normal limit * Any other cardiac condition that, in the opinion of the treatment physician, would make this protocol unreasonably hazardous for the patient * Patients unwilling or unable to comply with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a single injection reprogram immune cells to fight cancer?