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New drug rocbrutinib takes on pirtobrutinib in blood cancer showdown

NCT ID NCT07342478

Disease control Sponsor: Newave Pharmaceutical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 3 times

Summary

This study tests a new drug, rocbrutinib, against another drug, pirtobrutinib, in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer has returned or stopped responding to treatment. All participants have already tried a type of BTK inhibitor. The goal is to see which drug works better at controlling the cancer for longer. About 306 adults will take one pill daily until their disease worsens or side effects become too much.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2030

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: * Age ≥18 years; * Histologically confirmed CLL/SLL iwCLL 2018; * Relapsed or refractory disease requiring treatment; * Previously treated with prior lines of therapy including a covalent BTK inhibitor; * Measurable disease; * ECOG 0-2; * Adequate marrow, hepatic, and renal function; * TP53 mutation status confirmed by NGS; * 17p deletion status confirmed by FISH; Exclusion Criteria: * Prior ncBTKi or BTK degraders; * Richter's transformation; * Confirmed prolymphocytic leukemia; * Uncontrolled comorbidities or infections; * Known CNS involvement by CLL/SLL; * Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol; * Pregnancy or breastfeeding; * Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chromosome 17p deletion chronic lymphocytic leukemia/small lymphocytic lymphoma Leukemia, B-Cell Recurrence

As listed by the trial registrant

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

CLL CLL (chronic lymphocytic leukemia) CLL progression CLL, refractory CLL, relapsed CLL/SLL SLL SLL (small lymphocytic lymphoma)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical Oncology Associates - Spokane

    RECRUITING

    Spokane, Washington, 99208, United States

  • OSU Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • Optum Medical Group (Rhodes) P.C.

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • Orchard Healthcare Research

    RECRUITING

    Skokie, Illinois, 60077, United States

  • The Center for Cancer and Blood Disorders-Bethesda

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • UPMC Hillman Cancer Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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