Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes

6. september 2013 oppdatert av: Duke University

A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes

The purpose of this study is to find out what dose of lenalidomide is safe to use in combination with decitabine when given in people with myelodysplastic syndrome.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Myelodysplastic syndrome (MDS) is a group of different kinds of stem cell abnormalities. It is characterized by low blood counts and abnormal blood cell formation. These abnormal blood cells can cause fatigue, shortness of breath, infection, and bleeding. There is significant risk of developing acute leukemia in this disorder.

The only known curative therapy is an allogeneic bone marrow transplant of which the vast majority of patients with this disorder are not candidates. Currently three drugs have been approved for the treatment of MDS: azacytidine, decitabine and lenalidomide for low grade patients with a chromosome 5q abnormality. Azacytidine and decitabine have been demonstrated to improve blood counts, improve the quality of life, and decrease the risk of progression to AML or death in a sizable minority of MDS patients. A recent study of MDS patients who had responded clinically to decitabine revealed that their bone marrow biopsies still showed stromal abnormalities such as increased angiogenesis. Lenalidomide acts at the level of the stromal - marrow cell interaction. It is hypothesized that the combination of decitabine with lenalidomide may show synergistic results.

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center

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:

  • Understand and voluntarily sign an informed consent form.
  • Age >/=18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Myelodysplastic syndrome (documented by bone marrow biopsy) with IPSS score of Int-2 or High risk.
  • All previous MDS therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study.
  • ECOG performance status of </= 2 at study entry.
  • Laboratory test results within these ranges: Serum creatinine </= 2.5 mg/dL x ULN, Total bilirubin </= 2.5 mg/dL x ULN, AST (SGOT) and ALT (SGPT) </= 3 x ULN.
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  • Females of childbearing potential must have a negative serum pregnancy test within 10-14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. Must also agree to ongoing pregnancy testing.
  • Men must agree to use a latex condom during sexual contact even if they have had a successful vasectomy.
  • Disease free of prior malignancies for >/= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localized prostate cancer, or carcinoma "insitu" of the cervix or breast.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric
  • Pregnant or breast feeding females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Known hypersensitivity or reaction to thalidomide, lenalidomide or decitabine.
  • Any prior use of lenalidomide.
  • Concurrent use of other anti-cancer agents or anti-cancer treatments.
  • Known positive for HIV or active infectious hepatitis, type A, B or C.
  • History of thromboembolic event within past 6 months prior to enrollment.

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1
Lenalidomide (5mg) and Decitabine
Legemiddel: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Andre navn:
  • Dacogen
  • relimid
Eksperimentell: Cohort 2
Lenalidomide (10 mg) and Decitabine
Legemiddel: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Andre navn:
  • Dacogen
  • relimid
Eksperimentell: Cohort 3
Lenalidomide (15 mg) and Decitabine
Legemiddel: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Andre navn:
  • Dacogen
  • relimid
Eksperimentell: Cohort 4
Lenalidomide (20 mg) and Decitabine
Legemiddel: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Andre navn:
  • Dacogen
  • relimid
Eksperimentell: Cohort 5
Lenalidomide (25 mg) and Decitabine
Legemiddel: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Andre navn:
  • Dacogen
  • relimid

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Maximally tolerated dose (MTD)as defined by the protocol
Tidsramme: Cycle 1
Cycle 1

Sekundære resultatmål

Resultatmål
Tidsramme
svarvarighet
Tidsramme: 2 år
2 år
effect on cytogenetic abnormalities
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Samarbeidspartnere

Celgene Corporation

Etterforskere

  • Hovedetterforsker: Carlos de Castro, MD, Duke University

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. mars 2009

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

22. januar 2009

Først innsendt som oppfylte QC-kriteriene

23. januar 2009

Først lagt ut (Anslag)

26. januar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00010179

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. .

Kliniske studier på Myelodysplastiske syndromer

Kliniske studier på Lenalidomide, Decitabine

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Venezuela

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere