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Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

ConditionsRecurrent Chronic Lymphocytic LeukemiaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women >= 18 years of age.

Diagnosis of CLL or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria.

Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia

Massive (> 6 cm below left costal margin), progressive, or symptomatic splenomegaly

Disqualifiers

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation (biopsy based on clinical suspicion may be needed to rule out transformation)

Prior disease progression while on a BTK inhibitor

Prior disease progression while on venetoclax

Prior intolerance to acalabrutinib or venetoclax

Trial design

Design model

Single group

Treatments tested in this trial

  • Acalabrutinib

    Drug

    Given PO

  • Venetoclax

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (acalabrutinib, venetoclax)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Rate of undetectable measurable residual disease (uMRD)

MRD will be assessed using multicolor flow cytometry (sensitivity 10\^-4) (uMRD4) from peripheral blood (PB).

Time frame
At the end of treatment (26 cycles, 1 cycle = 28 days)

Secondary outcomes

1

Overall response rate (ORR)

Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

Time frame
Up to 10 years
2

Complete response (CR)

Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

Time frame
Up to 10 years
3

Partial response (PR)

Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

Time frame
Up to 10 years
4

Progression-free survival (PFS)

Kaplan-Meier curves and median time-to-event estimation with 95% confidence intervals will be presented.

Time frame
Time from receiving the first treatment to the first observation of disease progression or death from any cause, whichever occurs first, assessed up to 10 years

Other outcomes

Sponsors and contacts

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

Fred Hutchinson Cancer Center

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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