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

ConditionMantle Cell Lymphoma (MCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Histologically confirmed CD20+ mantle cell lymphoma.

No prior anti-lymphoma treatment.

Ann Arbor stage II-IV.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Acalabrutinib

    Drug

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

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Acalabrutinib in combination with RituximabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response(CR)

Defined as the proportion of patients who achieve complete remission

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

Secondary outcomes

1

Objective response rate(ORR)

The proportion of patients who achieve complete remission (CR) or partial remission (PR) .

Time frame
From the start of treatment with the investigational drug until 12 months
2

Duration of Response(DOR)

To investigate the preliminary anti-tumor efficacy

Time frame
The time from the patient's first efficacy assessment achieving CR or PR until disease progression, up to 5 years
3

Progression-free survival(PFS)

To investigate the preliminary anti-tumor efficacy

Time frame
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
4

Overall survival(OS)

To investigate the preliminary anti-tumor efficacy

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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