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Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients (FIL_GEMRO)

11. oktober 2019 oppdatert av: Fondazione Italiana Linfomi ONLUS

Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.

Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL (peripheral T-cell lymphoma) in a selected population of patients.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Alessandria, Italia, 15121
        • A.O. SS. Antonio e Biagio e C. Arrigo
      • Bologna, Italia, 40138
        • Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
      • Milano, Italia, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Torino, Italia, 10126
        • A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with histological diagnosis of PTCL according to the WHO (World Health Organization) classification
  • Age ≥ 18 years
  • Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy
  • Stage I-IV according to the Ann Arbor staging System
  • ECOG (Eastern Cooperative Oncology Group) Performance status ≤2
  • Normal renal and hepatic functions
  • Laboratory test results as follows:

    • Serum creatinine ≥ 2.0 mg/dL
    • Total bilirubin ≥ 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) £2 x ULN or £5 x ULN if hepatic metastases are present
    • Negative HIV HCV and HBV status
  • Adequate bone marrow reserve: Platelet count>100X109 cells/L or platelet count <75X109 cells/L if bone marrow disease involvement, absolute neutrophile count (ANC)> 1,5 X109, hemoglobin>8 g/dl.
  • Able to adhere to the study visit schedule and other protocol requirements
  • Cardiac ejection fraction (MUGA scan or echocardiography) > 45%
  • Life expectancy > 6 months
  • Females of childbearing potential (FCBP) must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
  • Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug.
  • Measurable disease of at least 2 cm as detected by CT scan, assessed by site radiologist
  • Patients or they legally authorized representative must provide written informed consent

Exclusion Criteria:

  • Any serious active disease or co-morbid medical condition (according to investigator's decision)
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation
  • Corrected QT interval > 480 msec (using the Fridericia formula)
  • Low K+ (<3.8 mmol/L) and low Mg+ (<0.85 mmol/L) levels, except if corrected before beginning the chemotherapy
  • Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study
  • Previous exposure to romidepsin or gemcitabine
  • CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  • Active opportunistic infection

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Romidepsin, Gemcitabine
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD (progression disease)
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Remission (CR) Rate
Tidsramme: 18 months
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Progression-Free Survival
Tidsramme: 24 months
The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS (progression-free survival) data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day. Percentage of participants is an estimate based on Kaplan-Meier method.
24 months
Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
Tidsramme: 24 months
OS (overall survival) is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive.
24 months
Safety - Frequency of Toxicities Grade 3 and 4
Tidsramme: 24 months
Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
24 months
Overall Response Rate (ORR)
Tidsramme: 24 months
ORR the proportion of patients who achieve CR (complete response), CRu (complete remission unconfirmed) or PR (partial response) relative to the per-protocol population. Disease response and progression will be evaluated according to the "Revised Response Criteria" for malignant lymphoma (Cheson et al. 2007).
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Pier Luigi Zinzani, Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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)

1. januar 2013

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først innsendt

28. mars 2013

Først innsendt som oppfylte QC-kriteriene

1. april 2013

Først lagt ut (Anslag)

2. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2019

Sist bekreftet

1. august 2018

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Kliniske studier på Romidepsin + Gemcitabine

3
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