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Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

ConditionsAnn Arbor Stage III Grade 1 Follicular LymphomaAnn Arbor Stage III Grade 2 Follicular LymphomaAnn Arbor Stage III Grade 3 Follicular LymphomaAnn Arbor Stage IV Grade 1 Follicular LymphomaAnn Arbor Stage IV Grade 2 Follicular LymphomaAnn Arbor Stage IV Grade 3 Follicular LymphomaGrade 3a Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies how well acalabrutinib, lenalidomide, and rituximab work in treating patients with CD20 positive stage III-IV, grade 1-3a follicular lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib, lenalidomide, and rituximab may help to control the disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a

Have had no prior systemic treatment for lymphoma

Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)

Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment

Disqualifiers

Known active central nervous system lymphoma or leptomeningeal disease, except subjects with a history of central nervous system lymphoma treated and in remission > 6 months

Evidence of diffuse large B-cell transformation

Grade 3b FL

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Acalabrutinib

    Drug

    Given PO

  • Lenalidomide

    Drug

    Given PO

  • Rituximab

    Biological/Vaccine

    Given IV

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Treatment (acalabrutinib, lenalidomide, rituximab)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete remission rate

Will be based on Cheson, Lugano classification 2014. The number and percentage of subjects with a complete remission at the end of treatment will be tabulated.

Time frame
(Up to end of treatment; 1 year)

Secondary outcomes

1

Overall response rate (complete response + partial response)

Will be based on Cheson, Lugano classification 2014. The number and percentage of subjects with an overall response rate will be tabulated. The best overall response rate will be recorded.

Time frame
(At the end of treatment ; 1 year )
2

Duration of response

Will be based on Cheson, Lugano classification 2014. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on duration of response. Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% confidence interval.

Time frame
From the time by which measurement criteria for complete response or partial response, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years
3

Progression-free survival within 24 months from treatment initiation

Will be estimated by the Kaplan-Meier method. Corresponding 95% confidence intervals will be summarized. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on progression-free survival.

Time frame
From the treatment start date (cycle 1, day 1) until the firstdate of objectively documented progressive disease or date of death from any cause, assessed up to 24 months
4

Progression-free survival

Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% confidence interval. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on progression-free survival.

Time frame
From the date of cycle 1, day 1 to the date of first documented progression, transformation to diffuse large B-cell lymphoma, initiation of new anti-lymphoma treatment, or death, assessed up to 3 years

Other outcomes

1

Alteration in immune cell subsets

Will assess whole exome sequencing (WES) of the tissue microenvironment to determine alteration in immune cell subsets. The association between somatic mutations and duration of response will be determined using Cox regression.

Time frame
Up to 3 years
2

Alteration in immune cell subsets

Will assess ribonucleic acid sequencing of tissue microenvironment to determine alteration in immune cell subsets. The frequencies of tumor infiltrating immune cells will be inferred, and their abundance correlated with duration of response.

Time frame
Up to 3 years
3

Cell free circulating deoxyribonucleic acid (DNA)

Will assess cell-free circulating DNA and association with response to therapy. The dynamics of response (i.e. rate of decline of tumor-derived somatic mutations) and ability to achieve negativity of molecular residual disease will be correlated with the duration of response.

Time frame
Up to 3 years

Sponsors and contacts

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

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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