Informations générales (source: ClinicalTrials.gov)
A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Interventional
Phase 1/Phase 2
Hoffmann-La Roche (Voir sur ClinicalTrials)
novembre 2022
septembre 2029
17 septembre 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | V�ronique MINARD-COLIN | 15/01/2024 17:51:11 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Pellegrin - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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