- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00689884
Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies
22. marts 2018 opdateret af: John M. Hill, Jr., MD, Dartmouth-Hitchcock Medical Center
A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies
The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs.
Also to determine the side effects of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All patients with hematologic malignancies undergoing stem cell mobilization in association with chemotherapy, prior to autologous stem cell transplantation.
- Prior Treatment:No parenteral cytotoxic chemotherapy within 2 weeks prior to initiation of chemo-mobilization therapy.
- Performance Status: Karnofsky > 70%
- Age >18
- Life Expectancy > 4 months
- Bone Marrow: bone marrow biopsy and aspirate
- Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 g/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
- Pulmonary function tests: DLCO > 55% predicted.
- Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
- Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease).
- Renal function (24 hour urine for creatinine clearance, if clinically indicated): The patient must have adequate renal function (creatinine clearance >50 ml/min), except when renal insufficiency is felt related to the underlying malignancy.
- No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival in the transplant setting.
- No significant established splenomegaly (i.e. spleen size > 20 cm)
- Informed written consent must be obtained. Patients must be able to give informed consent as a prerequisite to this procedure. The Informed Consent form will become part of his/her permanent record and a copy will be given to the patient.
Exclusion Criteria:
- Patients with greater than three pre-transplant chemotherapy regimens and/or poor stem cell reserve as demonstrated by significant marrow hypocellularity (<20%) will not be mobilized on the first phase regimen
- Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy.
- Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy.
- Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening dysrhythmia, or clinically significant obstructive/restrictive pulmonary disease.
- Serology positive for HIV.
- Positive pregnancy test or presence of lactation.
- Uncontrolled active infection.
- Documented hypersensitivity to any of the drugs used in the protocol.
- No concomitant,ongoing malignancy that is life-threatening, based on PI's evaluation.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Group A
All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
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Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg
Tidsramme: 2 years
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Outcome was not reported.
The study was terminated for lack of enrollment.
Data collection was terminated.
No data analysis was performed.
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.
Tidsramme: At each stage of pheresis for each enrolled subject for a maximum of 2 years.
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Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).
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At each stage of pheresis for each enrolled subject for a maximum of 2 years.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: John M Hill Jr., MD, Dartmouth-Hitchcock Medical Center
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
1. januar 2007
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
30. maj 2008
Først indsendt, der opfyldte QC-kriterier
3. juni 2008
Først opslået (Skøn)
4. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D0546
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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