Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill shows promise against Hard-to-Treat blood cancers

NCT ID NCT04014205

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called orelabrutinib in people with B-cell malignancies, such as certain lymphomas and leukemias. The drug works by blocking a protein that helps cancer cells grow. The trial has two parts: first finding the safest dose, then seeing how well it shrinks tumors. About 81 adults with relapsed or hard-to-treat cancers are taking part.

What this could mean

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

Active substance
Orelabrutinib (a targeted drug that blocks a protein called BTK to help stop cancer cell growth)
What this could lead to
If successful, this could provide a new treatment option for people with certain B-cell blood cancers, especially those who have not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors in many patients.

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

About 81 people

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

Started

Nov 2019

Expected to finish

Jun 2026

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: 1. Signed Informed Consent. 2. Age ≥ 18 years. 3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL. Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment. 4. Life expectancy (in the opinion of the investigator) of ≥ 4 months. 5. ECOG performance status of 0 \~1. 6. Must have adequate organ function. 7. Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection Exclusion Criteria: 1. Pregnant or breast-feeding or intending to become pregnant during the study. 2. Prior treatment with systemic immunotherapeutic agents. 3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV. 4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug. 5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML. 6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug. 7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor. 8. Active uncontrolled infections. 9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug. 10. Unresolved toxicities from prior anti-cancer therapy. 11. Medically apparent CNS lymphoma or leptomeningeal disease. 12. Current or previous history of CNS disease. 13. Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug. 14. Patients with another invasive malignancy in the last 2 years. 15. Significant cardiovascular disease or active pulmonary disease. 16. Received systemic immunosuppressive medications.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma chronic lymphocytic leukemia/small lymphocytic lymphoma follicular lymphoma mantle cell lymphoma marginal zone lymphoma

As listed by the trial registrant

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

Part 1：R/R B-cell malignancies Part 2：B-cell malignancies

Contacts and locations

Locations

  • Anne Arundel Medical Center (AAMC) Oncology and Hematology

    Annapolis, Maryland, 21401-3093, United States

  • Asclepes Research Centers - Weeki Wachee

    Weeki Wachee, Florida, 34607, United States

  • Carmel Medical Center

    Haifa, Israel

  • Cherkassy Regional Oncology Center

    Cherkasy, Ukraine

  • Clinical Research Alliance

    Westbury, New York, 11590, United States

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303, United States

  • Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

    Topeka, Kansas, 66606, United States

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270, United States

  • Florida Cancer Specialists (FCS) South

    Fort Myers, Florida, 33901, United States

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718, United States

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526, United States

  • Guthrie Cancer Center

    Sayre, Pennsylvania, 18840, United States

  • Institute of Blood Pathology and Transfusion Medicine

    Lviv, Ukraine

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi, Ukraine

  • Los Angeles Cancer Network - Good Samaritan Hospital Location

    Los Angeles, California, 90017, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic - Minnesota

    Rochester, Minnesota, 55905-0001, United States

  • Mayo Clinic-Mayo Clinic Hospital-Phoenix

    Phoenix, Arizona, 85054-4502, United States

  • Medical Oncology Associates PS (dba Summit Cancer Centers)

    Spokane, Washington, 99201, United States

  • National Cancer Institute

    Kyiv, Ukraine

  • Northwest Neurology - Rolling Meadows Office

    Elk Grove Village, Illinois, 60007, United States

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077, United States

  • Pacific Cancer Medical Center

    Anaheim, California, 92801-1824, United States

  • Prairie Lakes Cancer Center

    Watertown, South Dakota, 57201, United States

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203-1625, United States

  • Soroka Medical Center

    Beersheba, Israel

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510-2496, United States

  • St. Luke's Hospital - Medical and Diagnostic Center

    Kropyvnytskyi, Ukraine

  • Summit Medical Group

    Florham Park, New Jersey, 07932-0001, United States

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909-1327, United States

  • Tennessee Oncology - Chattanooga Oncology & Hematology Associates

    Chattanooga, Tennessee, 37404-1130, United States

  • The Oncology Institute of Hope & Innovation

    Whittier, California, 90603, United States

  • Transcarpathian Regional Clinical Hospital named after Andrii Novak

    Uzhhorod, Ukraine

  • Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC

    New Orleans, Louisiana, 70112, United States

  • University of Pittsburgh - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

More trials for these conditions

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