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Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

4. november 2014 opdateret af: University Hospital Plymouth NHS Trust

A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bortezomib may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.

PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib to see how well they work compared with combination chemotherapy alone in treating patients with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To evaluate the rates of overall response (complete response [CR], CR unconfirmed [CRu], and partial response).

Secondary

  • To evaluate the rates of CR and CRu.
  • To determine the median time to progression.
  • To determine the median overall survival.
  • To evaluate the toxicity and tolerability.
  • To compare the responses to these treatment regimens with those from first line therapy.
  • To compare the quality of life.

OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (CHOP): Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Arm I has been discontinued April 2012 on recommendation of the DMC.
  • Arm II (CHOP with bortezomib): Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.

In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.

After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • England
      • Basingstoke, England, Det Forenede Kongerige, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Birmingham, England, Det Forenede Kongerige, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, England, Det Forenede Kongerige, B75 7RR
        • Good Hope Hospital
      • Blackpool, England, Det Forenede Kongerige, FY3 8NR
        • Blackpool Victoria Hospital
      • Cambridge, England, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's Hospital
      • Dartford, England, Det Forenede Kongerige, DA2 8DA
        • Darent Valley Hospital
      • Harrogate, England, Det Forenede Kongerige, HG2 7SX
        • Harrogate District Hospital
      • Leeds, England, Det Forenede Kongerige, LS1 3EX
        • Leeds General Infirmary
      • Liverpool, England, Det Forenede Kongerige, L7 8XP
        • Royal Liverpool University Hospital
      • London, England, Det Forenede Kongerige, SE1 9RT
        • Guy's Hospital
      • Maidstone, England, Det Forenede Kongerige, ME16 9QQ
        • Mid Kent Oncology Centre at Maidstone Hospital
      • Newcastle-Upon-Tyne, England, Det Forenede Kongerige, NE1 4LP
        • Royal Victoria Infirmary
      • Norfolk, England, Det Forenede Kongerige, NR31 6LA
        • James Paget Hospital
      • Norwich, England, Det Forenede Kongerige, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Plymouth, England, Det Forenede Kongerige, PL6 8DH
        • Derriford Hospital
      • Prescot Merseyside, England, Det Forenede Kongerige, L35 5DR
        • Whiston Hospital
      • Southampton, England, Det Forenede Kongerige, SO16 6YD
        • Southampton General Hospital
      • Sunderland, England, Det Forenede Kongerige, SR4 7TP
        • Sunderland Royal Hospital
      • Taunton, England, Det Forenede Kongerige, TA1 5DA
        • Musgrove Park Hospital
      • Torquay, England, Det Forenede Kongerige, TQ2 7AA
        • Torbay Hospital
      • Truro, Cornwall, England, Det Forenede Kongerige, TR1 3LJ
        • Royal Cornwall Hospital
    • Scotland
      • Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Inverness, Scotland, Det Forenede Kongerige, 1V2 3UJ
        • Raigmore Hospital
    • Wales
      • Bangor, Wales, Det Forenede Kongerige, LL57 2PW
        • Ysbyty Gwynedd
      • Llanelli, Wales, Det Forenede Kongerige, SA14 8QF
        • Prince Philip Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of mantle cell lymphoma (MCL)

    • Expression of cyclin D1 or evidence of t(11;14) translocation by cytogenetics, FISH, or polymerase chain reaction
  • Refractory to or relapsed or progressed after first line antineoplastic therapy
  • Measurable disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
  • ANC ≥ 1,000/mm³ (not related to lymphoma)
  • Platelet count ≥ 30,000/mm³
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2 times ULN
  • Creatinine clearance ≥ 20 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Known serological positivity for HBV, HCV, or HIV
  • History of allergic reaction attributable to compounds containing boron or mannitol
  • Diagnosed or treated for a malignancy other than MCL within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or any in situ malignancy
  • Active systemic infection requiring treatment
  • Serious medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • Toxic effects of prior therapy or surgery must be resolved to ≤ grade 2
  • Prior splenectomy or localized radiotherapy allowed

  • Any prior chemotherapy regimen allowed

    • Chemotherapy may have been given in combination with rituximab
  • Concurrent enrollment in a nontreatment study allowed, provided it does not interfere with participation in this study

Exclusion criteria:

  • Prior bortezomib
  • Antineoplastic therapy within the past 3 weeks
  • Nitrosoureas within the past 6 weeks
  • Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody within the past 4 weeks
  • Radiotherapy within the past 3 weeks
  • Major surgery within the past 2 weeks
  • Concurrent investigational agents

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bortezomib plus CHOP

Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.

Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.

After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
Medicin: cyclophosphamid
Andet: spørgeskemaadministration
Medicin: vincristinsulfat
Medicin: doxorubicin hydrochlorid
Procedure: livskvalitetsvurdering
Medicin: bortezomib
Medicin: prednisolon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease progression
Tidsramme: 30 days and every 12 weeks
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
30 days and every 12 weeks
Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0
Tidsramme: continual after first drug dose
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
continual after first drug dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Plymouth NHS Trust

Efterforskere

  • Studiestol: Simon Rule, MD, Derriford Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. juni 2006

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

8. august 2007

Først indsendt, der opfyldte QC-kriterier

8. august 2007

Først opslået (Skøn)

9. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000559820
  • NCRN-Ply-26s
  • EU-20747
  • ISRCTN200600609024

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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