- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03617432
Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
30. august 2018 opdateret af: Jun Zhu, Peking University
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China.
The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
114
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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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer 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 til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria(NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded)including:Peripheral T-cell lymphoma, NOS,Angioimmunoblastic T-cell lymphoma,Anaplastic large-cell lymphoma, ALK negative,Enteropathy-associated T-cell lymphoma,Hepatosplenic T-cell lymphoma,Subcutaneous panniculitis T-cell lymphoma,Mycosis fungoides,Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
- Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
- Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
- Age 18-70 years, male or female;
- ECOG performance status 0-2;
- Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
- ALT and serum creatinine <1.5 times of normal maximum;
- Life expectancy no less than 3 months;
- Willing to sign the Informed Consent Form.
Exclusion Criteria:
- NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
- Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
- QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
- Patients with active hemorrhage;
- Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
- Patients with active infection or continuous fever within 14 days prior to enrollment;
- Had major organ surgery within 6 weeks prior to enrollment;
- Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum);
- Patients with mental disorders or those do not have the ability to consent;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- Patients with invasion of central nervous system ;
- Non-appropriate patients for the trial according to the judgment of the investigators.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Experimental group
Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
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Chidamide 15mg orally BIW.
Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Andre navne:
Cyclophosphamide(750mg/m2) was administered intravenously on d1.
Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
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Eksperimentel: Control group
Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
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Cyclophosphamide(750mg/m2) was administered intravenously on d1.
Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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complete remission (CR)rate
Tidsramme: up to 2 years
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The rate of patients who achieve complete remission after the treatment.
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up to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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objective response rate(ORR)
Tidsramme: up to 2 years
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The total proportion of patients with complete response(CR)and partial response(PR).
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up to 2 years
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progression-free survival(PFS)
Tidsramme: 2 years
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Time from treatment until disease progression or death.
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2 years
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overall survival(OS)
Tidsramme: 2 years after the last patient's enrollment.
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From the date of inclusion to date of death, irrespective of any cause.
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2 years after the last patient's enrollment.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
28. august 2018
Primær færdiggørelse (Forventet)
30. september 2020
Studieafslutning (Forventet)
30. september 2022
Datoer for studieregistrering
Først indsendt
1. august 2018
Først indsendt, der opfyldte QC-kriterier
1. august 2018
Først opslået (Faktiske)
6. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, T-celle
- Lymfom, T-celle, perifert
- Neoplasmer, eksperimentel
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Cyclofosfamid
- Etoposid
- Prednison
- Doxorubicin
- Vincristine
Andre undersøgelses-id-numre
- CSIIT-T13
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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