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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. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Gent, Belgien, 9000
        • Investigational Site Number 51
  • Danmark
      • København Ø, Danmark, 2100
        • Investigational Site Number 61
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B4 6NH
        • Investigational Site Number 11
      • Glasgow, Det Forenede Kongerige, G51 4TF
        • Investigational Site Number 13
  • Frankrig
      • Lyon, Frankrig, 69373
        • Investigational Site Number 42
      • Paris Cedex 05, Frankrig, 75248
        • Investigational Site Number 43
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Investigational Site Number 72
      • Rotterdam, Holland, 3015 GJ
        • Investigational Site Number 71
  • Israel
      • Petach Tikva, Israel, 4920235
        • Investigational Site Number 92
      • Tel-Aviv, Israel, 64239
        • Investigational Site Number 91
  • Italien
      • Genova, Italien, 16100
        • Investigational Site Number 21
      • Milano, Italien, 20133
        • Investigational Site Number 24
      • Padova, Italien, 35128
        • Investigational Site Number 23
      • Roma, Italien, 00165
        • Investigational Site Number 22
      • Torino, Italien, 10126
        • Investigational Site Number 26
  • Polen
      • Krakow, Polen, 30-663
        • Investigational Site Number 85
      • Wroclaw, Polen, 50-368
        • Investigational Site Number 84
  • Spanien
      • Barcelona, Spanien, 08035
        • Investigational Site Number 94
      • Madrid, Spanien, 28009
        • Investigational Site Number 93
  • Tjekkiet
      • Brno, Tjekkiet, 62500
        • Investigational Site Number 81
      • Praha 5 - Motol, Tjekkiet, 15006
        • Investigational Site Number 82
  • Tyskland
      • Frankfurt Am Main, Tyskland, 60590
        • Investigational Site Number 33
      • Freiburg, Tyskland, 79106
        • Investigational Site Number 34
      • Hamburg, Tyskland, 20246
        • Investigational Site Number 35
      • Hannover, Tyskland, 30625
        • Investigational Site Number 31
      • München, Tyskland, 80337
        • Investigational Site Number 36
  • Ungarn
      • Budapest, Ungarn, 1097
        • Investigational Site Number 83

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: plerixafor
160 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
240 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
320 μg/kg subcutaneous (SC) injection
Eksperimentel: 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).
Medicin: plerixafor
160 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
240 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
320 μg/kg subcutaneous (SC) injection
Eksperimentel: 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).
Medicin: plerixafor
160 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
240 μg/kg subcutaneous (SC) injection
Medicin: plerixafor
320 μg/kg subcutaneous (SC) injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients achieving at least a doubling of peripheral blood CD34+ count during Stage 2
Tidsramme: Up to 5 days
Up to 5 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of days of apheresis required to reach ≥2 × 10^6 CD34+ cells/kg
Tidsramme: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Yield of CD34+ cells for each apheresis
Tidsramme: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Total CD34+ cell yield
Tidsramme: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Percentage of patients proceeding to transplant
Tidsramme: Within 6 months of last apheresis
During Stage 1 and Stage 2
Within 6 months of last apheresis
Percentage of patients successfully engrafting
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to 5 days
During Stage 1 and Stage 2
Up to 5 days
Relapse rates
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 24 months post-transplant
During Stage 1 and Stage 2
Up to 24 months post-transplant
Survival rates
Tidsramme: 3, 6, 12 and 24 months post-transplant
During Stage 1 and Stage 2
3, 6, 12 and 24 months post-transplant

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genzyme, a Sanofi Company

Samarbejdspartnere

Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

3. marts 2014

Primær færdiggørelse (Faktiske)

9. maj 2017

Studieafslutning (Faktiske)

9. maj 2017

Datoer for studieregistrering

Først indsendt

28. januar 2011

Først indsendt, der opfyldte QC-kriterier

1. februar 2011

Først opslået (Skøn)

2. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DFI12860
  • 2010-019340-40 (EudraCT nummer)
  • MOZ15609 (Anden identifikator: Genzyme other study code)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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