Donnerstag, 2. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE

A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

Rekrutierend

NCT-Nummer:
NCT03571568

Studienbeginn:
Mai 2018

Letztes Update:
30.01.2024

Wirkstoff:
BI-1206

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
BioInvent International AB

Collaborator:
-

Studienleiter

Mats Jerkeman, MD PhD
Principal Investigator
Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden

Kontakt

Studienlocations
(3 von 22)

Krankenhaus Nordwest Klinik für Onkologie und Hämatologie
Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405
40207 Louisville
United StatesRekrutierend» Google-Maps
Hospital Sírio-Libanês
São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau, Dep Hematologia
Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
Barcelona
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia, L'Hospitalet de Llobregat
Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon-Oncología Médica
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario HM San Chinarro
Madrid
SpainNoch nicht rekrutierend» Google-Maps
University Hospital Fundacion Jimenez Diaz
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Arrixaca
Murcia
SpainNoch nicht rekrutierend» Google-Maps
Department of Oncology, Academical Hospital
751 85 Uppsala
SwedenAbgebrochen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in

combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL,

subtypes FL (except FL grade 3B), MZL, and MCL.

The trial consists of 2 main parts:

- Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose

escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC

dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV).

- Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in

combination with rituximab (administered IV).

Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle of induction

therapy with BI-1206 in combination with rituximab.

Subjects who show clinical benefit (complete response [CR], partial response [PR], or stable

disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206 ( using

the same dose and route of administration as induction therapy) and rituximab once every 8

weeks (relative to previous maintenance dose) for up to 6 maintenance cycles, or up to 1 year

from first dose of BI-1206 (whichever occurs first).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Are ≥ 18 years of age by initiation of study treatment.

- Have B-cell NHL proven by histology, with histological subtypes limited to follicular

lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL).

- Have measurable nodal disease

- Are willing to undergo lymph node biopsies or biopsies of other involved tissue

- Have relapsed disease or disease refractory to conventional treatment or for which no

standard therapy exists.

- Have received at least one line of conventional previous therapy which must include at

least one rituximab-based regimen.

- Have a life expectancy of at least 12 weeks

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Have CD20+ malignancy

- Have hematological and biochemical indices within prespecified ranges

Exclusion Criteria:

- Have had an allogenic bone marrow or stem cell transplant within 12 months

- Have presence of active chronic graft versus host disease

- Have current leptomeningeal lymphoma or compromise of the central nervous system.

- Have transformed lymphoma from a pre-existing indolent lymphoma.

- Have Waldenstrom's Macroglobulinemia or FL3B,

- Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other

corticosteroids) while on the study trial other than as pre-medication.

- Have known or suspected hypersensitivity to rituximab or BI-1206.

- Have cardiac or renal amyloid light-chain amyloidosis.

- Have received any of the following:

- Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206

- Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks

- Immunotherapy within 8 weeks

- Have ongoing toxic manifestations of previous treatments.

- Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).

- Have had major surgery from which the subject has not yet recovered.

- Are at high medical risk because of non-malignant systemic disease including active

infection on treatment with antibiotics, antifungals or antivirals.

- Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency

virus (HIV).

- Have an active, known or suspected autoimmune disease.

- Have concurrent congestive heart failure, prior history of class III/ IV cardiac

disease (New York Heart Association [NYHA]),

- Have current malignancies of other types

Studien-Rationale

Primary outcome:

1. Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab (Time Frame - During the 28-day treatment period on induction therapy):
Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL),subtypes follicular lymphoma (FL)(except FLgrade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).

2. Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT) (Time Frame - During the 28-day treatment period on induction therapy):
Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.

Secondary outcome:

1. Evaluation of PK parameters for BI-1206. (Time Frame - Up to 1 year):
Study the PK profile of BI-1206 when administered IV or SC in combination with rituximab in subjects with relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL and MCL.

2. Evaluation of PK parameters for rituximab during the BI-1206 treatment period. (Time Frame - Up to 1 year):
Study the PK profile of rituximab when administered in combination with BI-1206 (IV or SC).

3. Evaluation of ADA response to BI 1206. (Time Frame - Up to 1 year):
Assess the immunogenicity of BI-1206 when administered IV or SC in combination with rituximab.

4. Measurement of B cell depletion. (Time Frame - Up to 1 year):
Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab on the depletion of B-cells.

5. Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014). (Time Frame - Up to 1 year):
Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.

6. CD32b protein expression levels (Time Frame - Up to 1 year):
Investigate CD32b protein expression levels; evaluate any potential correlation with clinical responses.

Studien-Arme

  • Experimental: BI-1206 IV
    BI-1206 IV Standard 3+3 Dose-Escalation Design
  • Experimental: BI-1206 SC
    BI-1206 SC Adaptive Dose Escalation Design (Bayesian logistic regression model (BLRM)

Geprüfte Regime

  • BI-1206 (Rituximab):
    375 mg/m2, as per SmPC

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.