Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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England
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Birmingham, England, Regno Unito, B9 5SS
- Birmingham Heartlands Hospital
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Blackpool, England, Regno Unito, FY3 8NR
- Blackpool Victoria Hospital
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Canterbury, England, Regno Unito, CT2 7NR
- Kent and Canterbury Hospital
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Carshalton, England, Regno Unito, SM5 1AA
- St Helier Hospital
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Dartford Kent, England, Regno Unito, DA2 8DA
- Darent Valley Hospital
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Gillingham Kent, England, Regno Unito, ME7 5NY
- Medway Maritime Hospital
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Leeds, England, Regno Unito, LS1 3EX
- Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
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Leicester, England, Regno Unito, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, Regno Unito, L7 8XP
- Royal Liverpool and Broadgreen Hospitals NHS Trust
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Maidstone, England, Regno Unito, ME16 9QQ
- Maidstone Hospital
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Manchester, England, Regno Unito, M20 4BX
- Christie Hospital NHS Trust
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Truro, Cornwall, England, Regno Unito, TR1 3LJ
- Royal Cornwall Hospital
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Tunbridge Wells, Kent, England, Regno Unito, TN4 8AT
- Kent and Sussex Hospital
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Wishaw, England, Regno Unito, ML2 0DP
- Wishaw General Hospital
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Scotland
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Airdrie, Scotland, Regno Unito, ML6 0JF
- Monklands General Hospital
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Wales
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Cardiff, Wales, Regno Unito, CF14 4XW
- University Hospital of Wales
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Overall response rate as measured by NCI Response Criteria
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Misure di risultato secondarie
Misura del risultato |
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Tossicità
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Sopravvivenza globale a 2 anni
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Sopravvivenza libera da progressione a 2 anni
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Proportion of patients with undetectable minimal residual disease
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Peter Hillmen, MD, Leeds General Infirmary
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Leucemia
- Leucemia, linfocitica, cronica, cellule B
- Leucemia, linfoide
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Agenti antineoplastici, immunologici
- Ciclofosfamide
- Rituximab
- Fludarabina
- Fludarabina fosfato
- Mitoxantrone
Altri numeri di identificazione dello studio
- CTRU-NCRI-UKCLL01-FCM/FCM-R
- CDR0000485181 (Identificatore di registro: PDQ (Physician Data Query))
- EU-20626
- ROCHE-NCRI-UKCLL01-FCM/FCM-R
- ISRCTN77546448
- EUDRACT-2004-003982-34
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