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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Chemotherapy for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included: DLBCL, NOS, Activated B-cell type (ABC), DLBCL, NOS, Germinal center B-cell type (GCB), T-cell/histiocyte-rich large B-cell lymphoma, Primary cutaneous DLBCL, leg-type, EBV+ DLBCL, NOS, DLBCL associated with chronic inflammation, ALK+ large B-cell lymphoma, High-grade B-cell lymphoma, NOS, High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements. Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia/small lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.

Age greater than or equal to 18 years

Must not have

Known lymphomatous involvement of the CNS

The potential for all study treatments to be excreted in breast milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, breastfeeding must be discontinued.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initiation of study drug until 30 days after last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can improve the cure rate of aggressive B-cell lymphomas.

Who is the study for?

Adults aged 18+ with untreated aggressive B-cell lymphomas, specifically diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Participants must have measurable disease, adequate organ and marrow function, and be willing to use effective contraception. Pregnant women, those with CNS involvement by the cancer or certain other health conditions are excluded.

What is being tested?

The trial is testing if adding acalabrutinib (a pill) to standard chemotherapy regimens (DA-EPOCH-R or R-CHOP) along with rituximab improves cure rates in aggressive B-cell lymphomas like diffuse large B-cell lymphoma. The treatment includes up to six cycles of therapy lasting 21 days each.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response, bleeding risks due to blood disorders, possible liver enzyme changes indicating liver issues, fatigue from anemia or general drug effects, and infection risk due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an aggressive type of B-cell lymphoma and have not been treated for it.

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I am 18 years old or older.

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My condition is classified as Stage II, III, or IV by the Ann Arbor system.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has spread to my brain or spinal cord.

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I am not breastfeeding as it may harm my nursing infant due to treatment.

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I am not pregnant nor planning to become pregnant during the study.

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My lymphoma is not one of the excluded types like PCNSL or PMBL.

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I cannot swallow pills or have a condition that affects how my body absorbs them.

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I have or might have Progressive Multifocal Leukoencephalopathy.

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I have an uncontrolled immune system disorder that destroys my red blood cells.

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I have not had major surgery in the last 30 days or have fully recovered if I did.

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I do not have an active hepatitis C infection.

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I do not have active bleeding or a history of bleeding disorders like hemophilia.

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I do not have an ongoing serious infection.

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I need medication to prevent blood clots that is similar to warfarin.

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I need medication that affects how my body processes drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initiation of study drug until 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initiation of study drug until 30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study drug until 30 days after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Complete response rate

Event-free survival

Overall survival

+2 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment4 Interventions

Acalabrutinib 100 mg orally twice a day for 14 days; Following window: patients with \> or = to 25% tumor reduction, treat with DA-EPOCH-R or R-CHOP + acalabrutinib 100mg orally twice a day for the first 10 days, for 6 cycles; whereas, patients with \<25% tumor reduction, treat with DA-EPOCH-R or R-CHOP alone for 6 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

CHOP

2012

Completed Phase 3

~1460