A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Conditions

• Mature B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

6 Months - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Obinutuzumab — DRUG
  Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
• Glofitamab — DRUG
  Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3 Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter (Cycle length = 21 days)
• Rituximab — DRUG
  Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
• Ifosfamide — DRUG
  Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
• Carboplatin — DRUG
  Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
• Etoposide — DRUG
  Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
• Tocilizumab — DRUG
  Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events

Study Details

The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).

Key Dates

Start date

Nov 16, 2022

Status verified

Jun 2026

Primary completion

Nov 30, 2029

Completion

Nov 30, 2032

Study Design

Enrollment

65 participants (estimated)

Allocation

NA

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).
• Experimental: Arm B
  Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).

Primary Outcome Measure

Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A) [ Time Frame: Up to 3 treatment cycles (cycle length = 21 days) ]

Central Contacts

• Reference Study ID Number: CO43810 https://forpatients.roche.com
  888-662-6728
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (10)

Find similar trials in Birmingham, AL