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

Conditions

• Relapsed/Refractory Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tirabrutinib — DRUG
  Administered orally.
• Rituximab — DRUG
  Administered intravenously (IV).
• Temozolomide — DRUG
  Administered orally.

Study Details

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).

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tirabrutinib
  Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles.
• Active Comparator: Rituximab-Temozolomide (R-TMZ)
  Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Estimated up to 24 months ]

Central Contacts

• Clinical Team
  888-724-3274
  [email protected]

Locations (14)

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