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AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

10. února 2014 aktualizováno: Genzyme, a Sanofi Company

Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease

Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5*10^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Participants with HD who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this study. The only changes to the standard of care is the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD) analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor. Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the investigator's discretion.

The primary endpoint is the proportion of HD participants who collect ≥5*10^6 CD34+ cells/kg with this mobilization regimen. The secondary endpoints include the safety of this mobilization regimen, the proportion of participants who collect ≥2*10^6 CD34+ cells/kg, the change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and the number of days of apheresis required to obtain ≥5*10^6 CD34+ cells/kg. In addition, success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Typ studie

Intervenční

Zápis (Aktuální)

22

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Missouri
      • St Louis, Missouri, Spojené státy, 63110-1093
        • Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Diagnosis of HD eligible for autologous transplantation
  • No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy for the purpose of this study.)
  • 4 weeks since last cycle of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • White blood cell count (WBC) >3.0*10^9/L
  • Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
  • Platelet (PLT) count >100*10^9/L
  • Serum creatinine ≤2.2 mg/DL
  • Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
  • Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
  • Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
  • Negative for human immunodeficiency virus (HIV)

Exclusion Criteria:

  • A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
  • Patients who have failed previous collections
  • A residual acute medical condition resulting from prior chemotherapy
  • Hodgkin's disease involving the central nervous system
  • Acute infection
  • Fever (temp >38°C/100.4°F)
  • Patients whose actual body weight exceeds 150% of their ideal body weight
  • History of ventricular arrhythmias
  • History of paresthesias
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Participants with Hodgkin's Disease (HD)
Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation.
Lék: G-CSF Plus Plerixafor
Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Ostatní jména:
  • AMD 3100
  • Mozobil

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Časové okno: Day 5 up to Day 9
The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.
Day 5 up to Day 9

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Participant Counts of Adverse Events During the Treatment Period
Časové okno: Day 0 - approximately day 38

Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.

See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious.
Day 0 - approximately day 38
Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Časové okno: Day 5 up to day 9
The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.
Day 5 up to day 9
Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Časové okno: Days 4-5 (first dose of plerixafor to apheresis)
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Days 4-5 (first dose of plerixafor to apheresis)
Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg
Časové okno: Day 5 up to day 9
Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.
Day 5 up to day 9
Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment
Časové okno: Up to Month 13 (up to 12 months post transplant)
Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Up to Month 13 (up to 12 months post transplant)
Number of Days Post Transplantation to Platelet (PLT) Engraftment
Časové okno: Up to Month 13 (up to 12 months post transplant)
Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.
Up to Month 13 (up to 12 months post transplant)
Number of Participants With a Durable Graft at 12 Months
Časové okno: 13 months
Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.
13 months
Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor
Časové okno: Day 4
Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.
Day 4
Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor
Časové okno: Day 4
Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.
Day 4
Half-life (T1/2) Following a Single Dose of Plerixafor
Časové okno: Day 4
Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.
Day 4
Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor
Časové okno: Days 4-5
Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.
Days 4-5
Apparent Clearance (CL/F) of Single-dose Plerixafor
Časové okno: Day 4-5
Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).
Day 4-5
Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor
Časové okno: Day 4
The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.
Day 4

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Genzyme, a Sanofi Company

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2004

Primární dokončení (Aktuální)

1. října 2006

Dokončení studie (Aktuální)

1. ledna 2008

Termíny zápisu do studia

První předloženo

2. listopadu 2006

První předloženo, které splnilo kritéria kontroly kvality

2. listopadu 2006

První zveřejněno (Odhad)

6. listopadu 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

13. března 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. února 2014

Naposledy ověřeno

1. února 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AMD3100-2106

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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