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Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

30 augustus 2018 bijgewerkt door: 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

Studie Overzicht

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

114

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

      • Beijing, China, 100142
        • Werving
        • Beijing Cancer Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. 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;
  2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
  3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
  4. Age 18-70 years, male or female;
  5. ECOG performance status 0-2;
  6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
  7. ALT and serum creatinine <1.5 times of normal maximum;
  8. Life expectancy no less than 3 months;
  9. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
  2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
  3. 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;
  4. Patients have undergone organ transplantation;
  5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
  6. Patients with active hemorrhage;
  7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
  8. Patients with active infection or continuous fever within 14 days prior to enrollment;
  9. Had major organ surgery within 6 weeks prior to enrollment;
  10. 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);
  11. Patients with mental disorders or those do not have the ability to consent;
  12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
  13. Patients with invasion of central nervous system ;
  14. Non-appropriate patients for the trial according to the judgment of the investigators.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental group
Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Andere namen:
  • epidaza
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.
Experimenteel: Control group
Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
complete remission (CR)rate
Tijdsspanne: up to 2 years
The rate of patients who achieve complete remission after the treatment.
up to 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
objective response rate(ORR)
Tijdsspanne: up to 2 years
The total proportion of patients with complete response(CR)and partial response(PR).
up to 2 years
progression-free survival(PFS)
Tijdsspanne: 2 years
Time from treatment until disease progression or death.
2 years
overall survival(OS)
Tijdsspanne: 2 years after the last patient's enrollment.
From the date of inclusion to date of death, irrespective of any cause.
2 years after the last patient's enrollment.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 augustus 2018

Primaire voltooiing (Verwacht)

30 september 2020

Studie voltooiing (Verwacht)

30 september 2022

Studieregistratiedata

Eerst ingediend

1 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

1 augustus 2018

Eerst geplaatst (Werkelijk)

6 augustus 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2018

Laatste update ingediend die voldeed aan QC-criteria

30 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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