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Promising CLL combo trial halted early — only 5 patients enrolled

NCT ID NCT03514017

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This small Phase 2 trial tested two drugs — ibrutinib and pembrolizumab — in people with untreated high-risk chronic lymphocytic leukemia (CLL). The goal was to see if the combination could improve the body's immune function and shrink or control the cancer. However, the study was terminated early after enrolling only 5 participants, so we have very little information about how well it worked or what side effects occurred.

What this could mean

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

Active substance
Ibrutinib (Imbruvica) and pembrolizumab (Keytruda)
What this could lead to
If it worked, this combination might improve immune function and control high-risk CLL better than current treatments.
What could go wrong
The trial was terminated early with only 5 participants, so results are very limited. It is unclear if the combination is safe or effective, and it may not work as hoped.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

May 2019

Finished

May 2023

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: * Have high risk CLL * Have documented previously untreated CLL according to IWCLL criteria * Willing and able to provide written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Demonstrate adequate organ function * Able to take oral medication and willing to adhere to the medication regimen Exclusion Criteria: * Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment * Meets IWCLL criteria to start therapy * Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4 * Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia) * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment * Major surgery or a wound that has not fully healed within 4 weeks of first dose * Additional criteria may apply

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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

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

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Other studies related to the condition(s) this trial covers.