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IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

ConditionRelapsed/Refractory Primary Central Nervous System Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathology report confirming the diagnosis of B-cell PCNSL

Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.

Refractory disease: Participants whose best response to the last treatment was stable disease or PD.

One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)

Disqualifiers

Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions

Participants with non-B-cell PCNSL

Participants with systemic presence of lymphoma

Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirabrutinib

    Drug

    Administered orally.

  • Rituximab

    Drug

    Administered intravenously (IV).

  • Temozolomide

    Drug

    Administered orally.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: TirabrutinibExperimental treatment 1 intervention
Group B: Rituximab-Temozolomide (R-TMZ)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.

Time frame
Estimated up to 24 months

Secondary outcomes

1

Overall Response Rate (ORR)

ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR).

Time frame
Estimated up to 48 months]
2

Overall Survival (OS)

OS defined as time from randomization until death due to any cause.

Time frame
Estimated up to 48 months
3

Complete Response Rate (CRR)

CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu.

Time frame
Estimated up to 48 months
4

Best Overall Response (BOR)

BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first.

Time frame
Estimated up to 48 months]

Other outcomes

Sponsors and contacts

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

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Deciphera Pharmaceuticals, LLC

Collaborator

Source ClinicalTrials.gov
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