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

10 agosto 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tumour Size Reduction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2011

Completamento primario (Effettivo)

14 novembre 2017

Completamento dello studio (Effettivo)

28 febbraio 2018

Date di iscrizione allo studio

Primo inviato

26 luglio 2011

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2011

Primo Inserito (Stima)

27 luglio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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