Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia (IMCG-EAML)
12. juli 2016 oppdatert av: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC).
Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD.
The results have been clinically validated in several other centers in China, United States and Australia.
Based on these facts, to further validate the therapeutic efficacy, we propose a phase III clinical trial in which the de novo AML patients ≥60 years old are randomly assigned to receive standard induction and consolidation chemotherapy with or without microtransplantation.
Studietype
Intervensjonell
Registrering (Forventet)
196
Fase
- Fase 3
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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Beijing
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Beijing, Beijing, Kina, 100071
- Rekruttering
- Affiliated Hospital of Academy of Military Medical Sciences ,
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Ta kontakt med:
- AI HUISHENG, MD
- Telefonnummer: 86-1066947126
- E-post: HUISEHNGAI@163.COM
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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
60 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- Patients have not been treated before.
- Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
- Patients must have a HLA mismatched donor who should be able to provide informed consent.
- All genders and races are eligible.
- ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
- By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
- Donors must be able to safely undergo leukapheresis.
Exclusion Criteria:
- received operation 4 weeks before randomization
- acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
- active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
- occurred stroke or intracranial hemorrhage within 6 months before randomization.
- Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
- There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
- Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
- Any situation processed by the PI that will be damaged to the patients safety.
- Patients and / or authorized family member refuse to sign the consent.
- attend other clinical researchers in 3 months.
- Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
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: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: CT-group
standard induction and consolidation chemotherapy only, without microtransplantation
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Eksperimentell: MST-group
standard induction and consolidation chemotherapy with microtransplantation
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infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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the remission rate
Tidsramme: 2 months
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①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram:
absolute neutrophil count of more than 1.0×109/L，platelets of >100×109/L.
③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
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2 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disease Free Survival
Tidsramme: 2 years
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Measured from complete remission to the date of death or the date of last follow-up examination;
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2 years
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Overall Survival
Tidsramme: 2 YEAR
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measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;
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2 YEAR
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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treatment-related mortality
Tidsramme: 2 years
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Early mortality: death within 4 weeks after initiation of induction therapy
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2 years
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donor chimerism or microchimerism
Tidsramme: at count recovery prior to each new cycle of therapy, at 4 weeks after the last round of consolidation, and if still positive, every 3 months after completing therapy for up to 2 years
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at count recovery prior to each new cycle of therapy, at 4 weeks after the last round of consolidation, and if still positive, every 3 months after completing therapy for up to 2 years
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donor versus leukemia effect
Tidsramme: 2 years
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Analysis of donor WT1 positive CD8 T cells by flow cytometry
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2 years
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recipient versus leukemia effect
Tidsramme: 2 YEAR
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Analysis of recipient WT1 positive CD8 T cells by flow cytometry
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2 YEAR
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: AI HUISEHNG, MD, Affiliated Hospital of Academy of Military Medical Sciences
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 2014
Primær fullføring (Forventet)
1. juni 2018
Studiet fullført (Forventet)
1. juni 2018
Datoer for studieregistrering
Først innsendt
17. juni 2014
Først innsendt som oppfylte QC-kriteriene
20. juni 2014
Først lagt ut (Anslag)
24. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IMCG-EAML2014
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