Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

NCT06846489 | Recruiting Phase 2

• 1 other identifier: B2024-843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma

Conditions

Mantle Cell Lymphoma (MCL)

Outcome Measures

Primary Outcomes (1)

• Complete Response(CR)

  Defined as the proportion of patients who achieve complete remission

  From the start of treatment with the investigational drug until 12 months

Secondary Outcomes (4)

• Objective response rate(ORR)

  From the start of treatment with the investigational drug until 12 months

• Duration of Response(DOR)

  The time from the patient's first efficacy assessment achieving CR or PR until disease progression, up to 5 years

• Progression-free survival(PFS)

  From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, up to 5 years

• Overall survival(OS)

  From the date of enrollment until the date of death from ant cause, up to 5 years

Study Arms (1)

Acalabrutinib in combination with Rituximab

EXPERIMENTAL

Eligible patients will receive: Acalbrutinib : 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment. Rituximab: 375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months.

Drug: Acalabrutinib; Drug: Rituximab

Interventions

Acalabrutinib DRUG

100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.

Acalabrutinib in combination with Rituximab

Rituximab DRUG

375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months

Acalabrutinib in combination with Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Histologically confirmed CD20+ mantle cell lymphoma.
• No prior anti-lymphoma treatment.
• Ann Arbor stage II-IV.
• ECOG performance status 0-2, no deterioration \>2 weeks before baseline or first dose.
• Younger subjects (\<65) must meet:
• Low to intermediate risk sMIPI (0-5)
• Ki67 \< 50%
• No TP53 mutation (NGS)
• Lesion diameter ≤5 cm
• Non-blastoid, polymorphic disease
• At least one assessable lesion per Lugano 2014 criteria.
• Adequate organ and bone marrow function during screening.
• Female subjects must use contraception as per local regulations.
• Male subjects must agree to avoid sperm donation during the study and for 12 months post-rituximab.

You may not qualify if:

• Participants with tumor burden reduction prior to stem cell transplantation.
• History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.
• Any disease evidence deemed by the investigator to be detrimental to the patient's participation or likely to affect protocol adherence (e.g., severe or uncontrolled systemic disease, including uncontrolled hypertension or kidney transplant).
• History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.
• Received any investigational drug within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational drug.
• Underwent major surgery within 30 days prior to the first dose of the investigational drug. Note: If the participant has undergone major surgery, they must be fully recovered from any toxicity and/or complications related to the surgery before the first dose.
• A history of malignancy that could affect protocol adherence or interpretation of results, except for: a. Basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or prostate carcinoma in situ treated curatively at any time before the study. b. Other cancers that were treated surgically and/or with radiation, with no disease for ≥3 years without further treatment.
• Significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months before screening, or any NYHA Class 3 or 4 heart disease during screening. Note:Participants with well-controlled, asymptomatic atrial fibrillation are allowed.
• Refractory nausea and vomiting, difficulty swallowing formulations, or malabsorption syndrome; chronic gastrointestinal disease, gastric bypass, or weight-loss surgery (e.g., Roux-en-Y); partial or complete bowel obstruction, or previous major intestinal surgery that may interfere with the absorption, distribution, metabolism, or elimination of the investigational drug.
• Received a live-virus vaccine within 28 days prior to the first dose of the investigational drug.
• Known HIV infection.
• Any active major infection (e.g., bacterial, viral, or fungal, including subjects with positive CMV DNA PCR).
• Serologic evidence of active hepatitis B or C infection.
• History of stroke or intracranial hemorrhage within 6 months prior to the first dose of the investigational drug.
• History of bleeding disorders (e.g., hemophilia, Von Willebrand disease).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen university cancer center, Sun yat-sen university

Guangzhou, Guangdong, 51000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

acalabrutinib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Qingqing Cai

CONTACT

02087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 26, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): February 10, 2033
• Study Completion (Estimated): February 20, 2033
• Last Updated: June 3, 2025

Record last verified: 2025-02

Locations

CN (1)