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A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain

ConditionMantle-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

This is a single-arm, open-label, multicenter, non-indication seeking phase II trial to describe the efficacy and safety of patients with mantle cell lymphoma (MCL) receiving acalabrutinib in combination with R-CHOP for the front-line treatment of MCL in Spain.

Acalabrutinib will be administered until disease progression if medically appropriate, along with R-CHOP based on institutional standards. After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects receive monotherapy acalabrutinib until disease progression or treatment discontinuation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men or women.

Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers.

MCL requiring treatment and for which no prior systemic anticancer therapies have been received.

Unsuitable for autologous stem cell transplantation.

Disqualifiers

Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.

Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.

Adequately treated carcinoma in situ without current evidence of disease.

Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • Acalabrutinib + R-CHOP standard of care

    Drug

    Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP standard of care up to six 21-day cycles of the induction phase.

  • Acalabrutinib combination with Rituximab

    Drug

    If the subject achieves response during the induction phase, acalabrutinib will be administered 100 mg BID PO until disease progression and rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses.

  • Acalabrutinib monotherapy

    Drug

    If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Best Overall Response Rate (ORR)

Investigator-assessed best ORR (CR+PR) as per the Lugano Classification for NHL

Time frame
From acalabrutinib start to approximately 1 year thereafter

Secondary outcomes

1

Time To Response (TTR)

TTR, defined as the time from the date of acalabrutinib start to the first investigator-assessed CR or PR per the Lugano Classification for NHL. Measure of interest: median TTR.

Time frame
From acalabrutinib start to the first investigator assessed response; up to 30 months since the last subject in
2

Duration of Response (DoR)

DoR, defined as the time from the first documentation of investigator-assessed CR or PR to disease progression per the Lugano Classification for NHL or death from any cause in the absence of disease progression. Measure of interest: 30-month DoR.

Time frame
From the time of the first documentation of response to disease progression or death; up to 30 months since the last subject in
3

Progression-Free Survival (PFS)

PFS, defined as the time from the date of acalabrutinib start to investigator-assessed disease progression as per the Lugano Classification for NHL or death from any cause, whichever occurs first. Measure of interest: 30-month PFS.

Time frame
From acalabrutinib start to disease progression or death; up to 30 months since the last subject in
4

Overall Survival (OS)

OS, defined as the time from the date of acalabrutinib start to the date of death from any cause. Measure of interest: 30-month OS.

Time frame
From acalabrutinib start to death; up to 30 months since the last subject in

Other outcomes

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Apices Soluciones S.L.

Collaborator

Source ClinicalTrials.gov
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