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A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone

15 maggio 2017 aggiornato da: Genzyme, a Sanofi Company

A Phase 1/2 Combined Dose Ranging and Randomized, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilization of Haematopoietic Stem Cells Into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilization Regimens Alone in Pediatric Patients, Aged 1 to <18 Years, With Solid Tumours Eligible for Autologous Transplants.

This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages:

  • Stage 1 is a dose-escalation study.
  • Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study.

All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative).

Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

46

Fase

  • Fase 2
  • 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

  • Belgio
      • Gent, Belgio, 9000
        • Investigational Site Number 51
  • Cechia
      • Brno, Cechia, 62500
        • Investigational Site Number 81
      • Praha 5 - Motol, Cechia, 15006
        • Investigational Site Number 82
  • Danimarca
      • København Ø, Danimarca, 2100
        • Investigational Site Number 61
  • Francia
      • Lyon, Francia, 69373
        • Investigational Site Number 42
      • Paris Cedex 05, Francia, 75248
        • Investigational Site Number 43
  • Germania
      • Frankfurt Am Main, Germania, 60590
        • Investigational Site Number 33
      • Freiburg, Germania, 79106
        • Investigational Site Number 34
      • Hamburg, Germania, 20246
        • Investigational Site Number 35
      • Hannover, Germania, 30625
        • Investigational Site Number 31
      • München, Germania, 80337
        • Investigational Site Number 36
  • Israele
      • Petach Tikva, Israele, 4920235
        • Investigational Site Number 92
      • Tel-Aviv, Israele, 64239
        • Investigational Site Number 91
  • Italia
      • Genova, Italia, 16100
        • Investigational Site Number 21
      • Milano, Italia, 20133
        • Investigational Site Number 24
      • Padova, Italia, 35128
        • Investigational Site Number 23
      • Roma, Italia, 00165
        • Investigational Site Number 22
      • Torino, Italia, 10126
        • Investigational Site Number 26
  • Olanda
      • Amsterdam, Olanda, 1105 AZ
        • Investigational Site Number 72
      • Rotterdam, Olanda, 3015 GJ
        • Investigational Site Number 71
  • Polonia
      • Krakow, Polonia, 30-663
        • Investigational Site Number 85
      • Wroclaw, Polonia, 50-368
        • Investigational Site Number 84
  • Regno Unito
      • Birmingham, Regno Unito, B4 6NH
        • Investigational Site Number 11
      • Glasgow, Regno Unito, G51 4TF
        • Investigational Site Number 13
  • Spagna
      • Barcelona, Spagna, 08035
        • Investigational Site Number 94
      • Madrid, Spagna, 28009
        • Investigational Site Number 93
  • Ungheria
      • Budapest, Ungheria, 1097
        • Investigational Site Number 83

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

Da 1 anno a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 2 to < 18 years during stage 1 and 1 to < 18 years during stage 2
  • Ewing's sarcoma, soft tissue sarcoma, lymphoma, neuroblastoma, brain tumors or other malignancy (excluding any form of leukemia) requiring treatment with high dose chemotherapy and autologous transplant as rescue therapy
  • Eligible for autologous transplantation
  • Recovered from all acute significant toxic effects of prior chemotherapy
  • Adequate performance status (for patients ≥16 years of age, defined as Karnofsky score >60 and for patients <16 years of age, defined as Lansky score >60)
  • Absolute neutrophil count >0.75 × 10^9/L
  • Platelet count >50 × 10^9/L
  • Calculated creatinine clearance (using the Schwartz method): during study Stage 1, >80 mL/min/1.73m^2 and during study Stage 2, >60 mL/min/1.73m^2
  • Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase(SGOT), alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase (SGPT) and total bilirubin <3 × upper limit of normal
  • The patient and/or their parent/legal guardian is willing and able to provide signed informed consent
  • Patients who are sexually active must be willing to abstain from sexual intercourse or agree to use an approved form of contraception while receiving plerixafor and/or standard mobilization treatment and for at least 3 months following any plerixafor treatment

Exclusion Criteria:

  • Any form of leukemia
  • A co-morbid condition which, in the view of the Investigator, renders the patient at high-risk from treatment complications
  • Previous stem cell transplantation
  • Persistent high percentage marrow involvement prior to mobilization will be prohibited.
  • On-going toxicities (excluding alopecia) Grade ≥2 resulting from prior chemotherapy
  • Acute infection
  • Fever (temperature >38.5°C) - if fever is between 37°C and 38.5°C, infection must be excluded as a cause
  • Known HIV seropositivity, AIDS, hepatitis C or active hepatitis B infections
  • Positive pregnancy test in post pubertal girls
  • History of clinically significant cardiac abnormality or arrhythmia
  • Use of an investigational drug which is not approved in any indication either in adults or pediatrics within 2 weeks prior to the first dose of G-CSF to be administered as part of the patient's planned standard mobilization regimen, and/or during the study up until engraftment of the transplant. If patients are on investigational drugs as part of their anti-cancer regimen, this should be discussed with the Sponsor before screening. Drugs approved for other indications that are being used in a manner considered standard of care for this transplant procedure are allowed
  • The patient (and/or their parent/legal guardian), in the opinion of the Investigator, is unable to adhere to the requirements of the study

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Plerixafor 160 μg/kg
Patients will receive subcutaneous (SC) injection of 160 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions).
Droga: plerixafor
160 μg/kg subcutaneous (SC) injection
Droga: plerixafor
240 μg/kg subcutaneous (SC) injection
Droga: plerixafor
320 μg/kg subcutaneous (SC) injection
Sperimentale: Plerixafor 240 μg/kg
Patients will receive subcutaneous (SC) injection of 240 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions).
Droga: plerixafor
160 μg/kg subcutaneous (SC) injection
Droga: plerixafor
240 μg/kg subcutaneous (SC) injection
Droga: plerixafor
320 μg/kg subcutaneous (SC) injection
Sperimentale: Plerixafor 320 μg/kg
Patients will receive subcutaneous (SC) injection of 320 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions).
Droga: plerixafor
160 μg/kg subcutaneous (SC) injection
Droga: plerixafor
240 μg/kg subcutaneous (SC) injection
Droga: plerixafor
320 μg/kg subcutaneous (SC) injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Proportion of patients achieving at least a doubling of peripheral blood CD34+ count during Stage 2
Lasso di tempo: Up to 5 days
Up to 5 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of days of apheresis required to reach ≥2 × 10^6 CD34+ cells/kg
Lasso di tempo: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Yield of CD34+ cells for each apheresis
Lasso di tempo: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Total CD34+ cell yield
Lasso di tempo: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Percentage of patients proceeding to transplant
Lasso di tempo: Within 6 months of last apheresis
During Stage 1 and Stage 2
Within 6 months of last apheresis
Percentage of patients successfully engrafting
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant
Percentage of patients with durable engraftment
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant
Summary of adverse events (AEs)
Lasso di tempo: Up to 24 months after last transplant or 24 months after last dose (for patients that do not transplant within 6 months of last apheresis)
During Stage 1 and Stage 2
Up to 24 months after last transplant or 24 months after last dose (for patients that do not transplant within 6 months of last apheresis)
Duration of hospitalizations (planned or unplanned)
Lasso di tempo: Throughout the duration of the study
During Stage 1 and Stage 2
Throughout the duration of the study
Mobilization of tumor cells into peripheral blood
Lasso di tempo: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Relapse rates
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant
Occurrence of secondary malignancies
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant
Incidence of primary and secondary graft failure
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant
Time to secondary graft failure
Lasso di tempo: Up to 24 months post-transplant
During Stage 1 and Stage 2
Up to 24 months post-transplant
Survival rates
Lasso di tempo: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant

Collaboratori e investigatori

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

Sponsor

Genzyme, a Sanofi Company

Collaboratori

Sanofi

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

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

3 marzo 2014

Completamento primario (Effettivo)

9 maggio 2017

Completamento dello studio (Effettivo)

9 maggio 2017

Date di iscrizione allo studio

Primo inviato

28 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

1 febbraio 2011

Primo Inserito (Stima)

2 febbraio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DFI12860
  • 2010-019340-40 (Numero EudraCT)
  • MOZ15609 (Altro identificatore: Genzyme other study code)

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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