- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01426828
Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant
2. desember 2020 oppdatert av: University of Pennsylvania
Randomized Phase II Trial of CD3/CD28 Activated Id-KLH Primed Autologous Lymphocytes in Subjects With Myeloma Undergoing Autologous Transplant
This study will enroll myeloma subjects undergoing autotransplantation.
The primary objective of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28 activated autologous lymphocytes.
There will be 2 arms in the study, one receiving a DLI with non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.
Studieoversikt
Detaljert beskrivelse
The primary objectives of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense id-specific immunity than non id-KLH primed CD3/CD28 activated autologous lymphocytes.
The secondary objectives of this study is to demonstrate that doses of 1 times 10e10 Id-KLH primed CD3/CD28 autologous lymphocytes can be infused safely and effectively in more than 80 percent of eligible patients, to determine whether Id-KLH primed CD3/CD28 activated autologous lymphocytes and to determine if the presence of Id-specific immunity correlates with disease response.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Texas
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Houston, Texas, Forente stater, 77030
- University of Texas, MD Anderson Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
SCREEN #1 (Visit 1) Step 1:
- Diagnosis of symptomatic multiple myeloma.
- Less than 10 months after initiation of systemic therapy.
- One or two lines of induction therapy with commonly used regimens.
- Age greater than or equal to 18 years to less than or equal to 70 years at the time of enrollment.
- IgG paraprotein (not of IgG3 subtype) with a paraprotein peak (M-spike) of ≥0.2 g/dL. Alternatively subjects who have previously stored purified Id-specific protein on other clinical or laboratory protocols.
- Echocardiogram or MUGA with an ejection fraction of 45% or more and no uncompensated congestive heart failure or uncontrolled arrhythmias.
- Adequate pulmonary function as defined by FEV1, FVC and actual or corrected DLCO of 50% or greater of the predicted value for age, sex and size.
- Adequate renal function as defined by creatinine of 2.0 mg/dl or less or a creatinine clearance of 40cc/min or more.
- Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT less than 2 times upper limit of normal.
- Ability to sign written informed consent.
- Karnofsky performance status of at least 80% or more.
- Negative serum Beta HCG test in women of child bearing potential and agree to use a medically acceptable form of birth control while on the study drugs.
Exclusion:
- Subjects with melphalan-based induction
- Active uncontrolled infection
- HIV+ or active hepatitis B or C as defined by positive viral load or serology.
- Pre-existing autoimmune diseases, with exception of Hashimoto's thyroiditis.
- Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during Tcell collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids is permitted as well.
- Prior autologous or allogeneic transplant.
For this study, there will be no exceptions to eligibility granted.
4.2 PRE-VACCINE #1 ASSESSMENT (Visit 3) Step 2
Subjects must meet the following criteria to proceed with vaccination:
- Less than 9 months from randomization.
- Adequate renal function as defined by creatinine of 2.0 mg/dl or less or a creatinine clearance of 40cc/min or more.
- Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT less than 2 times upper limit of normal.
- Karnofsky performance status of at least 80% or more.
- At least 2 weeks from last chemotherapy.
- Negative serum Beta HCG test in women of child bearing potential.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Arm A
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
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CD3/CD28 activated autologous lymphocytes intravenously
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Annen: Arm B
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
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CD3/CD28 activated autologous lymphocytes intravenously
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Participants With Id-specific Immunity
Tidsramme: 180 DAYS
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Evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28 activated autologous lymphocytes.
RNA was isolated from CD4 and CD8 T cells pre-vaccine, and at day 30, 90 and 180 post-vaccine for gene expression analysis.
The Nanostring Human immunology V2 kit, a multiplex assay for 594 genes involved in the human immunology response, was used with an nCounter digital analyzer to quantify immune response gene expression levels.
Subjects were considered to have Id-specific immunity if they induced expression of effector (TBX21, KLRG1) and memory (CCL5) associated genes in CD8 T cells in post-vaccine time-points compared to baseline.
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180 DAYS
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ed Stadtmauer, MD, Abramson Cancer Center of the University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. desember 2017
Datoer for studieregistrering
Først innsendt
30. august 2011
Først innsendt som oppfylte QC-kriteriene
31. august 2011
Først lagt ut (Anslag)
1. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
Andre studie-ID-numre
- UPCC 07409
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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