- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03617432
Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
30. august 2018 oppdatert av: 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
Studieoversikt
Status
Ukjent
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
114
Fase
- Fase 2
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, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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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
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
28. august 2018
Primær fullføring (Forventet)
30. september 2020
Studiet fullført (Forventet)
30. september 2022
Datoer for studieregistrering
Først innsendt
1. august 2018
Først innsendt som oppfylte QC-kriteriene
1. august 2018
Først lagt ut (Faktiske)
6. august 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, T-celle
- Lymfom, T-celle, perifert
- Neoplasmer, eksperimentell
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Cyklofosfamid
- Etoposid
- Prednison
- Doxorubicin
- Vincristine
Andre studie-ID-numre
- CSIIT-T13
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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