Can a chemo-free cocktail tame mantle cell lymphoma?

NCT ID NCT07719556

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase II trial is testing whether a combination of three targeted drugs—orelabrutinib, obinutuzumab, and a short course of venetoclax—can effectively treat people newly diagnosed with mantle cell lymphoma (MCL). The study will enroll about 39 participants who have not received prior treatment. Researchers aim to see how many patients achieve a complete response and whether the cancer cells become undetectable at a molecular level.

What this could mean

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

Active substance
a combination of three drugs: orelabrutinib, obinutuzumab, and venetoclax
What this could lead to
If successful, this three-drug combination could offer a more effective, chemotherapy-free option for people newly diagnosed with mantle cell lymphoma, potentially leading to deeper remissions.
What could go wrong
This is an early-phase trial with only 39 participants, so results may not apply broadly. The combination may cause significant side effects, and it is not yet known if it will outperform standard treatments.

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

About 39 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

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: 1. Voluntarily participate and sign the informed consent form; 2. Age ≥ 18 years, male or female; 3. Life expectancy ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment; 5. Pathologically confirmed diagnosis of mantle cell lymphoma (MCL) and treatment-naïve; 6. Presence of measurable and/or evaluable lymphoma lesions; 7. Adequate bone marrow reserve, defined as: absolute neutrophil count \> 1.0×10⁹/L or platelet count \> 75×10⁹/L, unless cytopenias are considered to be related to bone marrow involvement by lymphoma and deemed recoverable by the investigator; 8. Hepatic function: AST (SGOT) and ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN) (in the absence of liver involvement) or ≤ 5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 9. Creatinine clearance ≥ 30 mL/min, calculated using the Cockcroft-Gault formula; 10. Able to comply with the study visit schedule and other protocol requirements; 11. All patients of childbearing potential must agree to use effective contraceptive measures during the study and for 24 months after study treatment discontinuation. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first dose of study treatment. Exclusion Criteria: 1. Received prior treatment for lymphoma within 2 weeks before study enrollment; 2. Any serious medical condition, including but not limited to: * Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents \[including diuretics\] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control); * Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association \[NYHA\] Class III \[moderate\] or Class IV \[severe\] cardiac disease); * Left ventricular ejection fraction (LVEF) \< 50%; * Symptomatic coronary artery disease (e.g., chest tightness, chest pain, palpitations, fatigue) or coronary artery disease requiring medical therapy; ⑤Severe bradycardia (heart rate \< 40 beats per minute \[bpm\]) with hypotension, dizziness, or syncope; patients with a history of arrhythmia should undergo cardiac evaluation; * Known active bacterial, viral, fungal, or other infection (excluding fungal infection of the nail bed), or major infection within 2 weeks prior to the first dose of study drug; * Moderate to severe hepatic impairment (Child-Pugh Class B or C); ⑧Active bleeding within 2 months prior to screening, or clear evidence of bleeding diathesis as judged by the investigator; ⑨Current pulmonary disease that impairs lung function, such as pulmonary fibrosis or drug-related pneumonitis, which is deemed intolerable by the investigator; ⑩Any psychiatric or cognitive disorder that may limit the patient's ability to understand, execute, or comply with the informed consent and study requirements; 3. Known active hepatitis C virus (HCV) infection; or other acquired or congenital immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) infection; 4. All patients with central nervous system (CNS) involvement by lymphoma; 5. Diagnosis of or receiving treatment for another malignancy other than lymphoma, except for the following: ①Malignancy that has been treated with curative intent and with no known active disease for ≥ 5 years prior to enrollment; ②Adequately treated basal cell carcinoma of the skin (excluding melanoma) with no evidence of disease; ③Adequately treated carcinoma in situ of the cervix with no evidence of disease; 6. Known hypersensitivity to any study drug; 7. Pregnant or breastfeeding women; 8. History of stroke or intracranial hemorrhage within 6 months prior to enrollment; 9. Requirement for anticoagulation therapy with warfarin or equivalent vitamin K antagonists; 10. Requirement for long-term treatment with strong cytochrome P450 3A (CYP3A) inhibitors; 11. Receipt of live attenuated vaccine within 4 weeks prior to enrollment.

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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.

How to take part

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

  1. The places running it

    2 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

  • Changzhou Second People's Hospital

    RECRUITING

    Changzhou, Jiangsu, China

  • Jiangsu province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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