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A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

17 novembre 2014 aggiornato da: Hoffmann-La Roche

Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

38

Fase

  • Fase 2

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

  • Germania
      • Erlangen, Germania, 91054
      • Grenzach-wyhlen, Germania, 79639
      • Göttingen, Germania, 37075
      • Hannover, Germania, 30625
      • Homburg/saar, Germania, 66424
      • Köln, Germania, 50924
      • Muenchen, Germania, 80336
      • Muenchen, Germania, 81377
      • Muenster, Germania, 48129
      • Stuttgart, Germania, 70376
      • Tübingen, Germania, 72076

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:

  • adult patients >= 18 years of age;
  • centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
  • relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion Criteria:

  • primary refractory lymphomas;
  • more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
  • clinically significant cardiac disease.

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
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MabThera/Rituxan
Droga: rituximab [MabThera/Rituxan]
375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
Lasso di tempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With a Clinical Response
Lasso di tempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Time to Best Response
Lasso di tempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
The median time, in months, from start of the treatment (first application) until best response (PR or CR).
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Duration of Remission
Lasso di tempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Median time, in months, between the documentation of CR or PR and PD in clinical responders.
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Time to Progression
Lasso di tempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
The median time, in months, from the start of treatment (first application) until detection of PD.
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Overall Survival (OS)
Lasso di tempo: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Number of Participants With a Clinical Response to Re-Treatment
Lasso di tempo: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).

Collaboratori e investigatori

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

Sponsor

Hoffmann-La Roche

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

1 gennaio 1997

Completamento primario (Effettivo)

1 febbraio 2008

Completamento dello studio (Effettivo)

1 febbraio 2008

Date di iscrizione allo studio

Primo inviato

25 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

25 novembre 2013

Primo Inserito (Stima)

2 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 novembre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • M39004

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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