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Promising new combo therapy targets Hard-to-Treat lymphoma

NCT ID NCT02180711

Disease control Sponsor: Acerta Pharma BV Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This study is testing a drug called acalabrutinib, alone or together with other drugs (rituximab and lenalidomide), in people with B-cell non-Hodgkin lymphoma that has come back or not responded to treatment. The goal is to see how safe these combinations are and whether they can shrink tumors. About 113 adults are taking part in this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acalabrutinib (a targeted cancer drug) alone or combined with rituximab and lenalidomide
What this could lead to
If successful, this could provide a new treatment option for people with certain types of non-Hodgkin lymphoma that have not responded to prior therapy.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. Side effects from the drug combinations are possible and being studied.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

113 people

The number who actually took part.

Started

Dec 2014

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Men and women ≥ 18 years of age. * Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment. * Part 2: For subject with relapsed or refractory MZL: Histologically confirmed MZL including splenic, nodal, and extranodal sub-types 1. Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4; 2. Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative * Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children. Exclusion Criteria: * •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or Qtc \>480 msec * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Breast feeding or pregnant

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Conditions

The condition(s) this trial relates to.

follicular lymphoma Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-Hodgkin lymphoma

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85719, United States

  • Research Site

    Downey, California, 90241, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Fountain Valley, California, 92708, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Coral Gables FL, Florida, 33146, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Chicago, Illinois, 60612, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    New Orleans, Louisiana, 70112, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Morristown, New Jersey, 07960, United States

  • Research Site

    Lake Success, New York, 11042, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Greenville, South Carolina, 29615, United States

  • Research Site

    Dallas, Texas, 75235, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78217, United States

  • Research Site

    Temple, Texas, 76508, United States

  • Research Site

    Salt Lake City, Utah, 84112, United States

  • Research Site

    Spokane, Washington, 99208, United States

  • Research Site

    Edmonton, Alberta, t6G1Z2, Canada

  • Research Site

    London, Ontario, N6A 5W9, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Palermo, 90146, Italy

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