Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial (FRAIL-06)

10. mars 2022 oppdatert av: Institut Bergonié

Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

Primary

  • To assess the therapeutic efficacy of rituximab, cyclophosphamide, vincristine sulfate, and prednisone with vs without liposome-encapsulated doxorubicin citrate, in terms of complete remission rate at 6 months, in vulnerable or frail elderly patients with stage II, III, or IV diffuse large B-cell non-Hodgkin lymphoma.
  • To assess the safety of these regimens in these patients.

Secondary

  • To evaluate the progression-free survival, event-free survival, and overall survival rates at 6 and 24 months in patients treated with these regimens.
  • To evaluate the overall response rate at 6 and 24 months in patients treated with these regimens.
  • To evaluate the duration of complete remission in patients treated with these regimens.
  • To evaluate the acute side effects (according to the International CTC scale) of these regimens in these patients.
  • To evaluate the geriatric condition and quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (R-COP regimen): Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.
  • Arm II (R-COPY regimen): Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.

After 3 courses of R-COP or R-COPY, patients undergo evaluation. Patients with disease progression or a response of < 25% are removed from the study. Patients with a response of ≥ 25% receive 3 more courses of R-COP or R-COPY, followed by rituximab IV alone on day 1 of courses 7 and 8 in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, some patients may undergo radiotherapy.

Patients complete quality of life and geriatric assessment questionnaires at baseline and periodically during study treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years.

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

      • Bordeaux, Frankrike, 33076
        • Institut Bergonié

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

70 år til 120 år (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse large B-cell non-Hodgkin lymphoma

    • Stage II, III, or IV disease (according to the WHO classification), including all morphological and clinical variants

      • No Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy allowed)
    • CD20+ disease
  • Has ≥ 1 measurable target lesion ≥ 1.1 cm (according to the International Workshop Criteria)
  • Poor physiological status, as defined by ≥ 1 of the following criteria:

    • WHO performance status 3
    • Clinical evaluation and measurement of LVEF that would preclude doxorubicin administration (i.e., LVEF < 50%)
    • Creatinine clearance < 50 mL/min
    • Serum bilirubin > 30 μmol/L
    • Severe comorbidity that would preclude the use of CHOP chemotherapy
  • Ineligible for standard R-CHOP therapy
  • No cerebral or meningeal involvement

PATIENT CHARACTERISTICS:

  • WHO performance status 0-3
  • ANC > 750/mm^3
  • Platelet count > 50,000/mm^3
  • LVEF > 35%
  • Able to receive either R-COP or R-COPY therapy
  • No congestive heart failure, serious arrhythmia, or myocardial infarction within the past 6 months
  • No other malignancy within the past 5 years except for adequately treated basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix
  • No active infection
  • No active viral hepatitis B or C by serology
  • No known HIV positivity
  • No hypersensitivity to rituximab, any of its excipients, or to murine proteins
  • No documented history of allergy to eggs or egg products
  • No psychological, familial, sociological, or geographical condition that would preclude compliance with study treatment or follow-up schedule

PRIOR CONCURRENT THERAPY:

  • No prior therapy for this cancer
  • No prior anthracycline administration with a cumulative dose > 240 mg/m² of doxorubicin hydrochloride or > 400 mg/m² of epirubicin hydrochloride
  • More than 30 days since prior participation in another clinical trial involving investigational drugs
  • No other concurrent antineoplastic agents

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
Eksperimentell: Arm I (R-COP regimen)
Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
Gis subkutant
Gis subkutant
Eksperimentell: Arm II (R-COPY regimen)
Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
Gis subkutant
Gis subkutant
Given IV

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants in Complete Remission 6 Months After Randomization
Tidsramme: 6 months after randomization

Complete remission [CR] is defined according to Cheson criteria. CR requires the following:

  1. Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities.
  2. All lymph nodes and nodal masses must have regressed to normal size. Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to ≤1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).
  3. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.
  4. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.
6 months after randomization
Number of Participants With Severe Toxicity
Tidsramme: 6 months after randomization

Severe toxicity, defined as febrile neutropenia or toxic death. Febrile neutropenia is defined in the International CTC toxicity scale as "fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever ≥ 38.5° C.

Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma.

6 months after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival Time
Tidsramme: from randomization, up to 5 years
OS is defined as the delay between the date of randomization and the date of death
from randomization, up to 5 years
Progression-free Survival Time
Tidsramme: from randomization, up to 5 years
Delay between the date of randomization and the date of progression or death. Progression is defined according to the Cheson criteria.
from randomization, up to 5 years

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Pierre Soubeyran, MD, PhD, Institut Bergonié

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)

2. desember 2008

Primær fullføring (Faktiske)

31. desember 2012

Studiet fullført (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først innsendt

29. mai 2009

Først innsendt som oppfylte QC-kriteriene

29. mai 2009

Først lagt ut (Anslag)

1. juni 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på cyklofosfamid

3
Abonnere