- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Förenta staterna, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Förenta staterna, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Förenta staterna, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Förenta staterna, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Förenta staterna, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, Förenta staterna, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, Förenta staterna, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, Förenta staterna, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Förenta staterna, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Förenta staterna, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Förenta staterna, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68198-3330
- University Of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Förenta staterna, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Förenta staterna, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Förenta staterna, 11030
- North Shore University Hospital
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New Hyde Park, New York, Förenta staterna, 11040
- Long Island Jewish Medical Center
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New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Förenta staterna, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Förenta staterna, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Förenta staterna, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Förenta staterna, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Förenta staterna, 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, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Förenta staterna, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Förenta staterna, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, Förenta staterna, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Bennington, Vermont, Förenta staterna, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Burlington, Vermont, Förenta staterna, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Förenta staterna, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Förenta staterna, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Förenta staterna, 23249
- Veterans Affairs Medical Center - Richmond
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
Andra namn:
25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Response
Tidsram: 2 months post consolidation
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2 months post consolidation
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Toxicity
Tidsram: 2 months post consolidation
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2 months post consolidation
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Kanti R. Rai, MD, Long Island Jewish Medical Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Leukemi, B-cell
- Leukemi
- Leukemi, lymfocytisk, kronisk, B-cell
- Leukemi, lymfoid
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, immunologiska
- Fludarabin
- Fludarabinfosfat
- Alemtuzumab
Andra studie-ID-nummer
- CALGB-19901
- U10CA031946 (U.S.S. NIH-anslag/kontrakt)
- CDR0000067506 (Registeridentifierare: NCI Physician Data Query)
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