An open-label, pilot study of fludarabine, cyclophosphamide, and alemtuzumab in relapsed/refractory patients with B-cell chronic lymphocytic leukemia

Blood

Volumn 118, Issue 15, 2011, Pages 4079-4085

  Montillo, Marco ^a   Tedeschi, Alessandra ^a   Petrizzi, Valeria Belsito ^b   Ricci, Francesca ^a   Crugnola, Monica ^c   Spriano, Mauro ^d   Spedini, Pierangelo ^e   Ilariucci, Fiorella ^f   Uziel, Lilj ^g   Attolico, Immacolata ^h   Vismara, Eleonora ^a   De Blasio, Angelo ⁱ   Zaccaria, Alfonso ^j   Morra, Enrica ^a  

^a OSPEDALE NIGUARDA CA GRANDA   (Italy)

^b General Hospital   (Italy)

^c UNIVERSITY OF PARMA   (Italy)

^d UNIVERSITY OF GENOA   (Italy)

^e CREMONA HOSPITAL   (Italy)

^f S MARIA NUOVA HOSPITAL   (Italy)

^g SAN PAOLO HOSPITAL   (Italy)

^h SAN CARLO HOSPITAL   (Italy)

ⁱ SANTA MARIA GORETTI HOSPITAL   (Italy)

^j SANTA MARIA DELLE CROCI HOSPITAL   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; CYCLOPHOSPHAMIDE; FLUDARABINE;

ADULT; AGED; ANEMIA; ARTICLE; B CELL LEUKEMIA; BLEEDING; CANCER RELAPSE; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DISEASE COURSE; DRUG DOSE INCREASE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEPATITIS B; HUMAN; HYPOTENSION; LUNG EMBOLISM; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REFRACTORY PERIOD; SEPSIS; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VIRUS ACTIVATION;

EID: 80054107144     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2011-05-351833     Document Type: Article

References (30)

1. Jemal A, Siegel R,Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009; 59(4):225-249.
2. Altekruse SF, Kosary CL, Krapcho M, et al. In Altekruse SF, Kosary CL, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975-2007. Bethesda, MD: National Cancer Institute; 2010.
3. Johnson S, Smith AG, Loffler H, et al. Multicentre prospective randomised trial of fludarabine versus cyclophosphamide, doxorubicin, and prednisone (CAP) for treatment of advanced-stage chronic lymphocytic leukaemia: the French Cooperative Group on CLL. Lancet. 1996;347(9013):1432-1438. (Pubitemid 26161205)
4. Keating MJ, O'Brien S, Lerner S, et al. Long-term follow-up of patients with chronic lymphocytic leukemia (CLL) receiving fludarabine regimens as initial therapy. Blood. 1998;92(4):1165-1171. (Pubitemid 28369029)
5. Rai KR, Peterson BL, Appelbaum FR, et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000;343(24):1750-1757.
6. Ricci F, Tedeschi A, Morra E, Montillo M. Fludarabine in the treatment of chronic lymphocytic leukemia: a review. Ther Clin Risk Manag. 2009;5(1):187-207.
7. Kano Y, Akutsu M, Tsunoda S, et al. In vitro cytotoxic effects of fludarabine (2-F-ara-A) in combination with commonly used antileukemic agents by isobologram analysis. Leukemia. 2000;14(3):379-388. (Pubitemid 30142859)
8. Yamauchi T, Nowak BJ, Keating MJ, Plunkett W. DNA repair initiated in chronic lymphocytic leukemia lymphocytes by 4-hydroperoxycyclophosphamide is inhibited by fludarabine and clofarabine. Clin Cancer Res. 2001;7(11):3580-3589. (Pubitemid 33069998)
9. O'Brien SM, Kantarjian HM, Cortes J, et al. Results of the fludarabine and cyclophosphamide combination regimen in chronic lymphocytic leukemia. J Clin Oncol. 2001;19(5):1414-1420. (Pubitemid 32202548)
10. Eichhorst BF, Busch R, Hopfinger G, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006;107(3):885-891. (Pubitemid 43156283)
11. Catovsky D, Richards S, Matutes E, et al. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet. 2007;370(9583):230-239. (Pubitemid 47069536)
12. Flinn IW, Neuberg DS, Grever MR, et al. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007;25(7):793-798. (Pubitemid 350002879)
13. Montillo M, Cafro AM, Tedeschi A, et al. Safety and efficacy of subcutaneous Campath-1H for treating residual disease in patients with chronic lymphocytic leukemia responding to fludarabine. Haematologica. 2002;87(7):695-700. (Pubitemid 34787139)
14. Moreton P, Kennedy B, Lucas G, et al. Eradication of minimal residual disease in B-cell chronic lymphocytic leukemia after alemtuzumab therapy is associated with prolonged survival. J Clin Oncol. 2005;23(13):2971-2979. (Pubitemid 46224116)
15. Fabian I, Flidel O, Gadish M, Kletter Y, Slavin S, Nagler A. Effects of CAMPATH-1 antibodies on the functional activity of monocytes and polymorphonuclear neutrophils. Exp Hematol. 1993;21(12):1522-1527. (Pubitemid 24216791)
16. Hale G, Xia MQ, Tighe HP, Dyer MJ,Waldmann H. The CAMPATH-1 antigen (CDw52). Tissue Antigens. 1990;35(3):118-127. (Pubitemid 20152978)
17. Gilleece MH, Dexter TM. Effect of Campath-1H antibody on human hematopoietic progenitors in vitro. Blood. 1993;82(3):807-812. (Pubitemid 23221659)
18. Keating MJ, Flinn I, Jain V, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99(10):3554-3561. (Pubitemid 34534522)
19. Stilgenbauer S, Zenz T, Winkler D, et al. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009;27(24):3994-4001.
20. Lundin J, Kimby E, Bjorkholm M, et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood. 2002;100(3):768-773. (Pubitemid 34832599)
21. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25(35):5616-5623.
22. Kennedy B, Rawstron A, Carter C, et al. Campath-1H and fludarabine in combination are highly active in refractory chronic lymphocytic leukemia. Blood. 2002;99(6):2245-2247. (Pubitemid 34525514)
23. Elter T, Borchmann P, Schulz H, et al. Fludarabine in combination with alemtuzumab is effective and feasible in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: results of a phase II trial. J Clin Oncol. 2005;23(28):7024-7031.
24. Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87(12):4990-4997. (Pubitemid 26189840)
25. Rawstron AC, Kennedy B, Moreton P, et al. Early prediction of outcome and response to alemtuzumab therapy in chronic lymphocytic leukemia. Blood. 2004;103(6):2027-2031. (Pubitemid 38326216)
26. National Cancer Institute. Common Terminology Criteria for Adverse Events, Version 4.0. http://ctep.cancer.gov/protocolDevelopment/electronic- applications/ctc.htm. Accessed 2010.
27. Badoux XC, Keating MJ, Wang X, et al. Fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy is highly effective treatment for relapsed patients with CLL. Blood. 2011;117(11):3016-3024.
28. Robak T, Dmoszynska A, Solal-Celigny P, et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol. 2010;28(10):1756-1765.
29. Lepretre S, Aurran T, Mahe B, et al. Immunochemotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R; FCR) versus fludarabine (F), cyclophosphamide (C) and MabCampath (Cam; FCCam) in previously untreated patients (pts) with advanced B-chronic lymphocytic leukemia (B-CLL): experience on safety and efficacy within a randomised multicenter phase III trial of the French Cooperative Group on CLL and WM (FCGCLL/MW) and the "Groupe Ouest-est d'Etudes Des Leucémies Aigües et Autres Maladies du Sang" (GOELAMS): CLL2007FMP (for fit medically patients) [abstract]. Blood. 2009;114(22):Abstract 538.
30. HOVON 68 protocol.Arandomized phase III study in previously untreated patients with biological high-risk CLL: fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab. http://www.hovon.nl/trials/trials-by-type/cll. html?action=showstudie&studie-id=6&categorie-id=8. Accessed April 4, 2010.