New cocktail targets tough lymphoma

NCT ID NCT02446236

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Jun 2015

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

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