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

Gå till den engelska sidan

Promising combo for rare blood cancer shows early potential

NCT ID NCT05051891

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested whether adding the targeted drug orelabrutinib to standard chemotherapy (R-CHOP) works better than chemotherapy alone for people with untreated mantle cell lymphoma, a rare blood cancer. Only 3 patients took part, and the study is now complete. Researchers measured how long patients lived without the cancer getting worse, overall response, and survival.

What this could mean

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

Active substance
Orelabrutinib combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
What this could lead to
If successful, this combination could offer a more effective first treatment for mantle cell lymphoma, potentially delaying disease progression.
What could go wrong
This was a very small completed trial with only 3 participants, so results may not apply broadly. The combination also carries risks from chemotherapy and targeted therapy side effects.

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

3 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2025

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

60 to 80 years

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. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator 2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report. 3. No previous systemic treatment for MCL. 4. ECOG physical strength score is 0-2. 5. Expected survival time \>6 months. 6. Voluntary written informed consent prior to screening. Exclusion Criteria: 1. Uncontrolled or significant cardiovascular diseases 2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment. 3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance; 4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures. 5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Treatment-naїve mantle cell lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Anhui Province Cancer Hospital

    Hefei, Anhui, 230009, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100143, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450008, China

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300052, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, Nanning, 530021, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 3300008, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    Shenyang, Liaojing, 110001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50011, China

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tumor in Hunan Province

    Hunan, Changsha, 410013, China

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041, China

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • he First Affiliated Hospital of Zhengjiang University

    Hangzhou, Zhejiang, 310003, China