JOURNAL ONKOLOGIE – STUDIE

iMATRIX GLO

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05533775

Studienbeginn:
November 2022

Letztes Update:
03.04.2024

Wirkstoff:
Obinutuzumab, Glofitamab, Rituximab, ifosfamide, Carboplatin, Etoposide, Tocilizumab

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-LaRoche

Kontakt

Reference Study ID Number: CO43810 https://forpatients.roche.com
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 21)

Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
48149 Muenster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Children's Hospital of Alabama
35233 Birmingham
United StatesRekrutierend» Google-Maps

UCSF Benioff Children's Hospital Oakland
94609 Oakland
United StatesRekrutierend» Google-Maps

Kaiser Permanente Oakland Medical Center
94611 Oakland
United StatesRekrutierend» Google-Maps

Kaiser Permanente - Roseville
95661 Roseville
United StatesRekrutierend» Google-Maps

Kaiser Permanente - Santa Clara
95051 Santa Clara
United StatesAktiv, nicht rekrutierend» Google-Maps

Johns Hopkins University
21205 Baltimore
United StatesRekrutierend» Google-Maps

Childrens Mercy Hosp & Clinics
64108 Kansas City
United StatesRekrutierend» Google-Maps

MSKCC
10065 New York
United StatesRekrutierend» Google-Maps

Cincinnati Children's Hospital Medical Center
45229 Cincinnati
United StatesRekrutierend» Google-Maps

Queensland Children?s Hospital
4101 South Brisbane
AustraliaRekrutierend» Google-Maps

Perth Children's Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps

Rigshospitalet; Ny Medicin til Børn med Kræft
2100 København Ø
DenmarkRekrutierend» Google-Maps

Hôpital Pellegrin; Service d'oncologie pédiatrique
33076 Bordeaux
FranceRekrutierend» Google-Maps

Gustave Roussy
94805 Villejuif
FranceRekrutierend» Google-Maps

IRCCS Ospedale Pediatrico Bambino Gesù; Clinical trial center - Pad. Salviati 1 floor
00165 Roma
ItalyRekrutierend» Google-Maps

Ospedaliera Ospedale Infantile Regina Margherita; Oncoematologia Pediatrica-Centro Trapianti Cellule
10126 Torino
ItalyRekrutierend» Google-Maps

Seoul National University Hospital- Pediatric Site
03080 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps

Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps

Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia
28009 Madrid
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

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).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age 6 months to < 18 years at the time of signing Informed Consent for Part 1 and

Cohort B of the study, and age 6 months to ≤ 30 years old at the time of signing

Informed Consent for Part 2 of the study

- Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate,

pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that

expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible),

including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of

first R/R disease for Cohort A and second or greater R/R disease for Cohort B

- Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable)

following first-line standard-of-care chemoimmunotherapy for Cohort A and following at

least two prior systemic chemoimmunotherapy regimens and who have exhausted all

available established therapies for Cohort B

- Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion,

defined as > 1.5 cm in its longest dimension, or at least one bi dimensionally

measurable extranodal lesion, defined as > 1.0 cm in its longest dimension; or

percentage of bone marrow involvement with lymphoma cells defined by cytomorphological

analysis of bone marrow aspirates

- Adequate performance status, as assessed according to the Lansky or Karnofsky

Performance Status scales: Participants < 16 years old: Lansky Performance Status ≥

50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%

- Adequate bone marrow, liver, and renal function

- Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus

(HCV)

- Negative HIV test at screening, with the following exception: Individuals with a

positive HIV test at screening are eligible provided they are stable on

anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an

undetectable viral load, and have not had a history of opportunistic infection

attributable to AIDS within the last 12 months

- Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment

- Participants and/or caregivers who are willing and able to complete clinical outcome

assessments throughout the study using either paper or interviewer methods

Exclusion Criteria:

- Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS

lymphoma

- Receipt of glofitamab prior to study enrollment

- Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade

≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)

- Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with

replacement therapy

- Participants with active infections which are not resolved prior to Day 1 of Cycle 1

- Prior solid organ transplantation

- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic

active Epstein-Barr viral infection (CAEBV)

- Active autoimmune disease requiring treatment

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

(or recombinant antibody-related fusion proteins) or known sensitivity or allergy to

murine products, except if the participant was able to safely receive it after initial

administration (consider consultation with Medical Monitor)

- History of confirmed progressive multifocal leukoencephalopathy

- Current or past history of uncontrolled non-malignant CNS disease, such as stroke,

epilepsy, CNS vasculitis, or neurodegenerative disease

- Evidence of significant and uncontrolled concomitant diseases that could affect

compliance with the protocol or interpretation of results

- Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab

pretreatment infusion (excluding biopsies) or anticipation of the need for major

surgery during study treatment

- Administration of a live, attenuated vaccine within 4 weeks before the start of study

treatment (obinutuzumab pretreatment) or at any time during the study treatment period

and within 12 months after end of study treatment

- Participants with any other diseases, metabolic dysfunction, physical examination

finding, or clinical laboratory finding giving reasonable suspicion of a disease or

condition that would contraindicate the use of an investigational drug

Studien-Rationale

Primary outcome:

1. 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))

2. Percentage of participants with adverse events (AEs) (Arm A) (Time Frame - Approximately 3 years)

3. Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A) (Time Frame - Up to 3 treatment cycles (cycle length = 21 days))

4. Serum concentration of glofitamab monotherapy (Arm B) (Time Frame - Up to 12 treatment cycles (Arm B) (cycle length = 21 days))

Secondary outcome:

1. Objective response rate (ORR) (Arms A and B) (Time Frame - Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days))

2. Duration of complete response (DOCR) (Arm A) (Time Frame - From the first occurrence of a documented complete response (CR) to documented disease progression or death from any cause (whichever occurs first) (approximately 3 years))

3. Progression-free survival (PFS) (Arm A) (Time Frame - From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) (approximately 3 years))

4. Event-free survival (EFS) (Arm A) (Time Frame - From enrollment to the first occurrence of disease progression, death from any cause, or start of new anti-lymphoma therapy (not including planned hematopoietic stem cell transplantation (HSCT)) (approximately 3 years))

5. Overall survival (OS) (Arms A and B) (Time Frame - From the first study treatment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years))

6. Percentage of participants who proceed to HSCT after up to three cycles of treatment (Arm A) (Time Frame - Up to 3 treatment cycles (cycle length = 21 days))

7. Duration of response (DOR) (Arm B) (Time Frame - From the first occurrence of a documented CR or partial response (PR) until documented disease progression or death from any cause, whichever occurs first (approximately 4 years))

8. Percentage of participants with AEs (arm B) (Time Frame - Approximately 3 years)

9. Serum concentration of obinutuzumab (Arms A and B) (Time Frame - Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days))

10. Serum concentration of rituximab (Arm A) (Time Frame - Up to 3 treatment cycles (cycle length = 21 days))

11. Percentage of participants with anti-drug antibodies (ADAs) (Arms A and B) (Time Frame - Up to 3 treatment cycles (cycle length = 21 days))

Studien-Arme

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).

Geprüfte Regime

Obinutuzumab:
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
Glofitamab:
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:
Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Ifosfamide:
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:
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:
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:
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events

Quelle: ClinicalTrials.gov

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