- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00004857
Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients.
OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Stati Uniti, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Stati Uniti, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Stati Uniti, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Stati Uniti, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Stati Uniti, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, Stati Uniti, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Stati Uniti, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, Stati Uniti, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Stati Uniti, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Stati Uniti, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Stati Uniti, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Stati Uniti, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Stati Uniti, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Stati Uniti, 11030
- North Shore University Hospital
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New Hyde Park, New York, Stati Uniti, 11040
- Long Island Jewish Medical Center
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New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Stati Uniti, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Stati Uniti, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Stati Uniti, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Stati Uniti, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Stati Uniti, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Stati Uniti, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Stati Uniti, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Stati Uniti, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Stati Uniti, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, Stati Uniti, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Bennington, Vermont, Stati Uniti, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Burlington, Vermont, Stati Uniti, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Stati Uniti, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Stati Uniti, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Stati Uniti, 23249
- Veterans Affairs Medical Center - Richmond
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Specific Diagnosis of B-Cell CLL
1.1 An absolute lymphocytosis of > 5,000/µl
1.1.1 Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes.
1.1.2 Bone marrow examination must include at least a unilateral aspirate and biopsy. The aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL. The overall cellularity must be normocellular or hypercellular.
1.1.3 Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23, CD24) with the CD5 antigen, in the absence of other pan-T-cell markers. Additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density. Patients with bright surface immunoglobulin levels must have CD23 co-expression.
1.2 Staging
1.2.1 Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV) per the protocol.
1.2.2 Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
- Massive or progressive splenomegaly and/or lymphadenopathy
- Presence of weight loss > 10% over the preceding 6 month period;
- Grade 2 or 3 fatigue
- Fevers > 100.5°C or night sweats for greater than 2 weeks without evidence of infection
- Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months.
- Prior Treatment: No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL.
- No medical condition requiring chronic use of oral corticosteroids.
- Age ≥18 years.
- Performance Status 0 - 2.
- No HIV disease. Due to alterations in host immunity, patients with HIV may not be enrolled.
- Non-pregnant and non-nursing. Due to the unknown teratogenic potential of Campath-1H, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.
- Initial Required Laboratory Values:
Creatinine <1.5 x upper limit of institutional normal value Coomb's Testing NEGATIVE
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Fludarabine + Campath-1H
Standard of care induction with fludarabine followed by consolidation antibody therapy
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30 mg subQ injection tiw for 6 weeks
Altri nomi:
25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Response
Lasso di tempo: 2 months post consolidation
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2 months post consolidation
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Toxicity
Lasso di tempo: 2 months post consolidation
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2 months post consolidation
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Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Kanti R. Rai, MD, Long Island Jewish Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- Rai KR, Freter CE, Mercier RJ, Cooper MR, Mitchell BS, Stadtmauer EA, Santabarbara P, Wacker B, Brettman L. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002 Sep 15;20(18):3891-7. doi: 10.1200/JCO.2002.06.119.
- Morrison VA, Peterson BL, Rai KR, et al.: Alemtuzumab increases serious infections in patients with previously untreated chronic lymphocytic leukemia (CLL) receiving fludarabine-based therapy: a comparative analysis of 3 Cancer and Leukemia Group B studies (CALGB 9011, 9712, 19901). [Abstract] Blood 110 (11): A-756, 2007.
- Byrd JC, Peterson BL, Rai KR, Hurd D, Hohl R, Perry MC, Gockerman J, Nattam S, Larson RA. Fludarabine followed by alemtuzumab consolidation for previously untreated chronic lymphocytic leukemia: final report of Cancer and Leukemia Group B study 19901. Leuk Lymphoma. 2009 Oct;50(10):1589-96. doi: 10.1080/10428190903150839.
- Rai KR, Byrd JC, Peterson B: Subcutaneous alemtuzumab following fludarabine for previously untreated patients with chronic lymphocytic leukemia (CLL): CALGB study 19901. [Abstract] Blood 102 (11 Pt 1): A-2506, 2003.
- Rai KR, Byrd JC, Peterson BL, et al.: A phase II trial of fludarabine followed by alemtuzumab (Campath-1H) in previously untreated chronic lymphocytic leukemia (CLL) patients with active disease: Cancer and Leukemia Group B (CALGB) study 19901. [Abstract] Blood 100 (11 Pt 1): A-772, 2002.
- Jones JA, Ruppert AS, Zhao W, Lin TS, Rai K, Peterson B, Larson RA, Marcucci G, Heerema NA, Byrd JC. Patients with chronic lymphocytic leukemia with high-risk genomic features have inferior outcome on successive Cancer and Leukemia Group B trials with alemtuzumab consolidation: subgroup analysis from CALGB 19901 and CALGB 10101. Leuk Lymphoma. 2013 Dec;54(12):2654-9. doi: 10.3109/10428194.2013.788179. Epub 2013 May 9.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
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
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Fludarabina
- Fludarabina fosfato
- Alemtuzumab
Altri numeri di identificazione dello studio
- CALGB-19901
- U10CA031946 (Sovvenzione/contratto NIH degli Stati Uniti)
- CDR0000067506 (Identificatore di registro: NCI Physician Data Query)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su alemtuzumab
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German CLL Study GroupCompletatoLeucemia linfatica cronicaGermania
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Genzyme, a Sanofi CompanyCompletato
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Genzyme, a Sanofi CompanyTerminatoLinfoma non-HodgkinStati Uniti
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)RitiratoLinfomaStati Uniti, Australia, Regno Unito, Canada, Francia
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Karolinska University HospitalSchering Nordiska ABCompletato
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Latin American Cooperative Onco-Haematology Group...SconosciutoMicosi fungoide | Sindrome di SézaryPerù
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Genzyme, a Sanofi CompanyTerminatoNeoplasie ematologicheStati Uniti
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Ontario Clinical Oncology Group (OCOG)Sunnybrook Health Sciences Centre; Genzyme, a Sanofi CompanyCompletatoLinfomi periferici a cellule TCanada
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Genzyme, a Sanofi CompanyCompletatoLeucemia linfocitica cronica a cellule BStati Uniti
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German CLL Study GroupCompletato