DCHA as Postremission Therapy for AML With t(8;21)
1. marts 2018 opdateret af: Li Yu, Chinese PLA General Hospital
Decitabine in Combination With Chidamide, Homoharringtonine and Ara-c (DCHA) as Postremission Therapy for Acute Myeloid Leukemia With t(8;21) :A Multicenter Prospective Study
Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy.
Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis.
The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with （tyrosine kinase）KIT mutation.
So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.
Studieoversigt
Detaljeret beskrivelse
Treatment regimen
HA:
homoharringtonine 2mg IV d1-5 cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h
DCHA:
Decitabine 20mg/m2 d8-12 Chidamide 30mg twice/week P.O. for two weeks per cycle (four doses totally) cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h d1,3,5 homoharringtonine 2mg IV d10-14
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Li-Xin Wang, MD. Ph.D.
- Telefonnummer: 010-66957676
- E-mail: wanglixin1991@sohu.com
Undersøgelse Kontakt Backup
- Navn: Li Yu, MD. Ph.D.
- Telefonnummer: 010-66957678
- E-mail: chunhuiliy@yahoo.com
Studiesteder
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-
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Beijing, Kina, 100853
- Rekruttering
- Chinese PLA General Hospital
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Kontakt:
- Li Yu, M.D. Ph.D.
- Telefonnummer: 86-010-55499003
- E-mail: chunhuiliyu@yahoo.com
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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
14 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
• Written informed consent provided.
- The patients were diagnosed AML-M2 with t(8;21) (q22;q22) chromosomal changes and positive acute myeloid leukemia(AML1)-eight twenty one(ETO) fusion gene according to the 2008 World Health Organization (WHO) diagnostic criteria for malignant myeloid diseases.
- Males or females aged ≥18 years, < 65 years.
- Eastern Cooperative Oncology Group（ECOG） performance status 0-3.
- Life expectancy ≥3 months.
- The morphology was Complete remission (CR) or Cri after 2 cycles of anthracycline induced chemotherapy.
- No serious disease with heart, lung, liver and kidney.
- The ability to understand and be willing to sign the Informed Consent Form of the experiment.
- Patient who can start the investigational therapy within 3-6 weeks after the complete resection
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
- Known allergic to prior treatment with drugs contained by the trial programme or with a chemical structure similar medicine.
- Pregnancy, breast-feeding women and childbearing age patients who do not want to take contraceptive measures.
- Active serious infection.
- Patients with extramedullary lesions.
- Patients who use drugs or drink alcohol for a long time to influence the evaluation of results.
- Patients with mental illness or other conditions are unable to obtain knowledge and consent, and can not cooperate with the requirements of the completion of the test treatment and examination steps.
- Patients with a history of the clinical significance of Q and T interval（QTc） prolongation (male > 450ms, female >470ms), ventricular tachycardia (VT), atrial fibrillation (AF), degree of heart block, muscle infarction (MI) within 1 years, congestive heart failure (CHF), with symptoms and drug therapy in patients with coronary heart disease.
- Patients with abnormal liver function (total bilirubin > 1.5 x ULN, ALT/AST > 2.5 x ULN, or liver invasion ALT/AST > 5x ULN ), renal function abnormality (serum creatinine > 1.5 x ULN).
- The researchers decided that patient was not appropriate to take part in the experiment.
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: t(8;21)AML
chemotherapy 5-Aza-2'-deoxycytidine IV 20mg/m2 d8-12 homoharringtonine IV 2mg d1-5 chidamide P.O.
30mg twice/W cytarabine IV 1000mg/m2(<60 year old) 500mg/m2(>60 year old) IV q12h d1,3,5
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chidamide, decitabine, homoharringtonine, cytarabine
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression free survival
Tidsramme: 2 years
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To evaluate the disease progression free survival of DCHA as postremission therapy for acute myeloid leukemia with t(8;21) .
Progression free survival (PFS)- defined as the time from remission for the first time to the first documented disease progression.
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival
Tidsramme: 2 years
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Overall survival (OS)- defined as the length of time from trial treatment to death.
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2 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: Li Yu, MD. Ph.D, Chinese PLA 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 (Faktiske)
1. januar 2018
Primær færdiggørelse (Forventet)
31. december 2019
Studieafslutning (Forventet)
31. december 2020
Datoer for studieregistrering
Først indsendt
23. februar 2018
Først indsendt, der opfyldte QC-kriterier
1. marts 2018
Først opslået (Faktiske)
5. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 301-XYK-004
Plan for individuelle deltagerdata (IPD)
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INGEN
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