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New combo therapy shows promise for rare blood cancer

NCT ID NCT02717624

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 2 times

Summary

This early-stage trial tests two new drug combinations for people with untreated mantle cell lymphoma, a rare blood cancer. One group gets acalabrutinib plus standard chemo and an antibody; the other gets acalabrutinib plus a targeted pill and the same antibody. The main goal is to check safety and find the best doses. About 72 adults will take part across multiple centers.

What this could mean

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

Active substance
Acalabrutinib combined with bendamustine and rituximab, or with venetoclax and rituximab
What this could lead to
If successful, this could point toward a more effective first treatment for mantle cell lymphoma, potentially improving how long patients stay in remission.
What could go wrong
This is a very early (Phase 1) trial with only 72 people, so the main goal is safety, not proof of effectiveness. The combination drugs also have known side effects like low blood counts and infections.

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

72 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Aug 2027

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. * Pathologically confirmed MCL. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest. * Treatment Naive MCL patients requiring treatment with no exposure to prior therapies. Exclusion Criteria: * Significant cardiovascular disease such as uncontrolled or untreated 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.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study * Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass * Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug * Breastfeeding or pregnant * Concurrent participation in another therapeutic clinical trial.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

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

Mantle cell lymphoma (MCL)

Contacts and locations

Locations

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Hackensack, New Jersey, 07601, United States

  • Research Site

    Morristown, New Jersey, 07960, United States

  • Research Site

    Lake Success, New York, 11042, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Seattle, Washington, 98122, United States

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Krakow, 30-510, Poland

  • Research Site

    Lodz, 93-510, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Warsaw, 02-106, Poland

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