Promising combo for rare blood cancer shows early potential
NCT ID NCT05051891
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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3 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Jun 2025
- Lead sponsor
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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
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60 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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Anhui Province Cancer Hospital
Hefei, Anhui, 230009, China
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100143, China
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Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
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Henan Tumor Hospital
Zhengzhou, Henan, 450008, China
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Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
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Shandong Provincial Hospital
Jinan, Shandong, 250021, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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The First Affiliated Hospital of Guangxi Medical University
Guangxi, Nanning, 530021, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 3300008, China
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
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The First Hospital of China Medical University
Shenyang, Liaojing, 110001, China
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The First Hospital of Jilin University
Changchun, Jilin, 130021, China
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011, China
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Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
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Tumor in Hunan Province
Hunan, Changsha, 410013, China
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West China Hospital,Sichuan University
Chengdu, Sichuan, 610041, China
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Wuhan Union Hospital
Wuhan, Hubei, 430022, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
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he First Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, 310003, China