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Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

1. august 2013 opdateret af: Cancer Research UK

A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Leukæmi

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia.
Determine the overall response rate, defined as complete or partial remission, in these patients.

Secondary

Determine the proportion of patients with undetectable minimal residual disease.
Determine the 2-year progression-free survival of these patients.
Determine the 2-year overall survival of these patients.
Determine the toxicity of this regimen.

OUTLINE: This is a randomized, controlled, open-label, parallel group, multicenter study. Patients are stratified according to prior treatment with fludarabine (refractory vs not refractory or naive). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral fludarabine* and oral cyclophosphamide* on days 1-5 and mitoxantrone hydrochloride IV on day 1.
Arm II: Patients receive fludarabine*, cyclophosphamide*, and mitoxantrone hydrochloride as in arm I. Patients also receive rituximab IV on day 1.

NOTE: *If the oral regimen is not tolerated, patients may receive fludarabine IV and cyclophosphamide IV on days 1-3.

Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

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
  - Birmingham, England, Det Forenede Kongerige, B9 5SS
    - Birmingham Heartlands Hospital
  - Blackpool, England, Det Forenede Kongerige, FY3 8NR
    - Blackpool Victoria Hospital
  - Canterbury, England, Det Forenede Kongerige, CT2 7NR
    - Kent and Canterbury Hospital
  - Carshalton, England, Det Forenede Kongerige, SM5 1AA
    - St Helier Hospital
  - Dartford Kent, England, Det Forenede Kongerige, DA2 8DA
    - Darent Valley Hospital
  - Gillingham Kent, England, Det Forenede Kongerige, ME7 5NY
    - Medway Maritime Hospital
  - Leeds, England, Det Forenede Kongerige, LS1 3EX
    - Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
  - Leicester, England, Det Forenede Kongerige, LE1 5WW
    - Leicester Royal Infirmary
  - Liverpool, England, Det Forenede Kongerige, L7 8XP
    - Royal Liverpool and Broadgreen Hospitals NHS Trust
  - Maidstone, England, Det Forenede Kongerige, ME16 9QQ
    - Maidstone Hospital
  - Manchester, England, Det Forenede Kongerige, M20 4BX
    - Christie Hospital NHS Trust
  - Truro, Cornwall, England, Det Forenede Kongerige, TR1 3LJ
    - Royal Cornwall Hospital
  - Tunbridge Wells, Kent, England, Det Forenede Kongerige, TN4 8AT
    - Kent and Sussex Hospital
  - Wishaw, England, Det Forenede Kongerige, ML2 0DP
    - Wishaw General Hospital
- Scotland
  - Airdrie, Scotland, Det Forenede Kongerige, ML6 0JF
    - Monklands General Hospital
- Wales
  - Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
    - University Hospital of Wales

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

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia requiring therapy
Previously treated with ≥ 1 chemotherapeutic regimen

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy ≥ 12 weeks
Creatinine clearance ≥ 30 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment
Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies
No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy)
No active infection
No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride
No prior rituximab, either alone or in combination with chemotherapy

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: Randomiseret
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overall response rate as measured by NCI Response Criteria

Sekundære resultatmål

Resultatmål
Toksicitet
Samlet overlevelse efter 2 år
Progressionsfri overlevelse ved 2 år
Proportion of patients with undetectable minimal residual disease

Samarbejdspartnere og efterforskere

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

Sponsor

Cancer Research UK

Efterforskere

Studiestol: Peter Hillmen, MD, Leeds General Infirmary

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

Hillmen P, Cohen DR, Cocks K, Pettitt A, Sayala HA, Rawstron AC, Kennedy DB, Fegan C, Milligan DW, Radford J, Mercieca J, Dearden C, Ezekwisili R, Smith AF, Brown J, Booth GA, Varghese AM, Pocock C; NCRI CLL Sub-Group. A randomized phase II trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab in previously treated chronic lymphocytic leukaemia. Br J Haematol. 2011 Mar;152(5):570-8. doi: 10.1111/j.1365-2141.2010.08317.x. Epub 2011 Jan 14.

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. juli 2005

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

13. juni 2006

Først indsendt, der opfyldte QC-kriterier