Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia
Studieoversigt
Status
Betingelser
Detaljeret 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.
In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect.
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: yajing huang
- Telefonnummer: +8615811031508
- E-mail: yajing_huang@163.com
Undersøgelse Kontakt Backup
- Navn: mei guo
- Telefonnummer: +8615811031508
- E-mail: 15811031508@163.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina
- Rekruttering
- The Fifth Medical Center of PLA General Hospital
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Kontakt:
- yajing huang
- Telefonnummer: +8615811031508
- E-mail: yajing_huang@163.com
-
Kontakt:
- mei guo
- Telefonnummer: +8615811031508
- E-mail: 15811031508@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
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Køn, der er berettiget til at studere
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
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: MST for unfit
Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy. Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses. |
HLA-mismatched donor peripheral stem cell infusion
Andre navne:
azacytidine 50-75mg/m2
Andre navne:
Venetoclax 100-300mg/d ×3d，400mg 4-28d
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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the remission rate
Tidsramme: 2month
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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;
|
2month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Disease Free Survival
Tidsramme: 2 year
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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 year
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
treatment-related mortality
Tidsramme: 2 year
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Early mortality: death within 4 weeks after initiation of induction therapy
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2 year
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Samarbejdspartnere og efterforskere
Sponsor
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Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
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Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MST-EAML2020
Plan for individuelle deltagerdata (IPD)
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