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BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

10 août 2020 mis à jour par: Boehringer Ingelheim

A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin

The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 12200
        • Charité - Universitätsmedizin Berlin
      • Dresden, Allemagne, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Frankfurt am Main, Allemagne, 60590
        • Universitatsklinikum Frankfurt
      • Göttingen, Allemagne, 37075
        • Universitätsmedizin Göttingen, Georg-August-Universität
      • Hamburg, Allemagne, 20099
        • Asklepios Klinik St. Georg
      • Heidelberg, Allemagne, 69120
        • Universitätsklinikum Heidelberg
      • Jena, Allemagne, 07740
        • Universitätsklinikum Jena
      • Ulm, Allemagne, 89081
        • Universitatsklinikum Ulm
  • Corée, République de
      • Seoul, Corée, République de, 135-710
        • Samsung Medical Center
      • Seoul, Corée, République de, 110-744
        • Seoul National University Hospital
  • France
      • Marseille Cedex 09, France, 13273
        • INS Paoli-Calmettes
      • Pierre Bénite, France, 69495
        • HOP Lyon Sud

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion criteria:

  1. Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
  2. Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
  3. Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
  4. Relapse or progression of disease with an indication for therapy as per investigator's judgement
  5. Life expectancy of =3 months
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria:

  1. Primary central nervous system (CNS) lymphoma or known CNS involvement
  2. Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
  3. Last chemotherapy <4 weeks prior to visit 1
  4. Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
  5. Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
  6. High-dose therapy with stem cell support <6 months prior to visit 1
  7. Radio-immunotherapy <3 months prior to visit 1

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
Médicament: BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Délai: From the first administration of trial medication to 7 days after the second administration, upto 36 days
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
From the first administration of trial medication to 7 days after the second administration, upto 36 days
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Délai: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
From the first administration of trial medication to 7 days after the second administration, up to 36 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Tumour Size Reduction
Délai: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, & positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Best Overall Response Based on All Assessment
Délai: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)

Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:

  1. Complete remission (CR)
  2. Complete remission unconfirmed (CRu)
  3. Partial remission (PR)
  4. Stable disease (SD)
  5. progressive disease (PD)
Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
Best Overall Response Based on Imaging Data
Délai: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:

  1. Complete remission
  2. Complete remission unconfirmed
  3. Partial remission
  4. Stable disease:
  5. progressive disease
Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Progression Free Survival (PFS)
Délai: from first treatment until disease progression or death from any cause, up to 12 months.

PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required:

• Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
from first treatment until disease progression or death from any cause, up to 12 months.
Failure Free Survival (FFS)
Délai: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required:

• Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2011

Achèvement primaire (Réel)

14 novembre 2017

Achèvement de l'étude (Réel)

28 février 2018

Dates d'inscription aux études

Première soumission

26 juillet 2011

Première soumission répondant aux critères de contrôle qualité

26 juillet 2011

Première publication (Estimation)

27 juillet 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 août 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 août 2020

Dernière vérification

1 août 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1270.2
  • 2010-024456-29 (Numéro EudraCT)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Essais cliniques sur BI 836826

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