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New combo therapy shows promise for rare blood cancer

NCT ID NCT07206264

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new treatment for mantle cell lymphoma, a rare blood cancer. It combines chemotherapy with targeted drugs to see if it can keep the cancer from coming back. The study involves 45 people who have not been treated before, and uses scans and blood tests to guide therapy.

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 45 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

60 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. Gender not limited, aged ≥65 years, or aged ≥60 years but \<65 years and unsuitable or unwilling to undergo stem cell transplantation due to the following reasons: 1. Creatinine clearance rate \>30 mL/min, but \<70 mL/min; 2. Presence of other comorbidities that contraindicate high-intensity induction chemotherapy; 3. High-risk patients who are expected to fail stem cell mobilization and collection (such as those with bone marrow infiltration, diabetes, thrombocytopenia). Patients who are unwilling to receive autologous stem cell transplantation, considering potential complications post-transplantation (such as prolonged bleeding, immunodeficiency, hemorrhage, severe infections), and relapse. 2. Histologically confirmed mantle cell lymphoma at stages II-IV; 3. Patients who have not received prior treatment; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Adequate organ function: 1. Hematological: Absolute neutrophil count ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75 g/L. If accompanied by bone marrow involvement: Absolute neutrophil count ≥1.0×109/L, platelets ≥50×109/L, hemoglobin ≥50 g/L. 2. Biochemical: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 times ULN. 6. Coagulation function: International normalized ratio (INR) ≤1.5 times ULN; 7. Expected survival time ≥12 months; 8. Voluntarily sign a written informed consent form before the trial screening. Exclusion Criteria: 1. Progression to higher-grade disease or central nervous system involvement; 2. Uncontrolled or significant cardiovascular diseases: 1. Within 6 months prior to the first administration of the study drug, there was New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or a need for treatment of arrhythmia at the time of screening, with left ventricular ejection fraction (LVEF) \< 50%; 2. Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and unclassified cardiomyopathy); 3. A history of clinically significant QTc interval prolongation, or a QTc interval \>470 ms for females or \>450 ms for males during the screening period; 4. Participants with symptomatic or medication-requiring coronary artery disease; 5. Participants with uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite adequate therapy with three antihypertensive agents (including a diuretic) for at least one month, or requiring four or more antihypertensive agents to achieve control. 3. Participants with active bleeding within 2 months prior to screening, those currently on anticoagulant therapy, or those deemed by the investigator to have a significant risk of bleeding; 4. History of deep vein thrombosis or pulmonary embolism within the past 6 months; 5. Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery is defined as any surgical procedure requiring general anesthesia; diagnostic endoscopy is not considered major surgery; 6. Active infection or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with detectable HBV DNA), hepatitis C virus (HCV) antibody positive, HIV/AIDS, or other severe infectious diseases; 7. Participants with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced lung disease, drug-related lung disease, or other conditions affecting pulmonary function; 8. Pregnant women, breastfeeding women, and fertile participants unwilling to use effective contraception; 9. Participants requiring continuous use of drugs with strong inhibition or induction effects on cytochrome P450 CYP3A4; 10. Other conditions deemed unsuitable for participation in this trial by the investigator.

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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

    5 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

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Hebei Medical University Tumor Hospital

    Shijiazhuang, Hebei, China

  • Shandong Cancer Hospital

    Jinan, Shandong, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, China

More trials for these conditions

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