Dasatinib in Relapsed Chronic Lymphocytic Leukemia
15. november 2017 opdateret af: Philip C. Amrein, M.D., Massachusetts General Hospital
Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow.
Recent research shows that a key enzyme in CLL cells is responsible for cell survival.
This enzyme is called LYN kinase.
Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells.
Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.
Studieoversigt
Detaljeret beskrivelse
- After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures.
- Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned.
- During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week.
- Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing.
- Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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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:
- 18 years of age or older
- CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
- Must have failed at least 1 prior fludarabine containing regimen or have failed at least 2 non-fludarabine containing regimens or have a contraindication to fludarabine use
- ECOG performance status of 2 or better
- Adequate organ function to tolerate chemotherapy
- Adequate method of contraception
Exclusion Criteria:
- Pregnant or breast-feeding women
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- History of clinically significant ventricular arrhythmias
- Prolonged QTc interval on pre-entry electrocardiogram
- Uncontrolled hypertension
- Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Patient known to be HIV positive
- Known significant bleeding disorder unrelated to CLL
- Drugs that interfere with platelet function or coagulation must be stopped at least 7 days prior to entry
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Dasatinib treatment
All patients were treated with dasatinib pills by mouth as treatment.
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Taken orally once daily.
Participants may continue on study treatment as long as there is no disease progression or serious side effects.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Objective Response
Tidsramme: 2 years
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Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months:
Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following:
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Complete Response Rate
Tidsramme: 1 year
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The number of participants with a 100% reduction in nodal mass.
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1 year
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Median Time to Disease Progression
Tidsramme: 1 year
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The median time to disease progression, measured from the start of treatment.
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1 year
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Median Overall Survival
Tidsramme: 3 years
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The median survival time, as measured from the start of treatment until death from any cause.
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Philip Amrein, MD, Massachusetts General Hospital
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. december 2006
Primær færdiggørelse (Faktiske)
1. oktober 2010
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
20. februar 2007
Først indsendt, der opfyldte QC-kriterier
20. februar 2007
Først opslået (Skøn)
22. februar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi, B-celle
- Leukæmi
- Leukæmi, lymfatisk, kronisk, B-celle
- Leukæmi, lymfoid
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Dasatinib
Andre undersøgelses-id-numre
- 06-211
- CA 180-045
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 .