11 juli 2012: recente publicatie over Clolar - clofarabine bij ALL - acute lymfatische leukemie staat onderaan dit artikel. Het volledige studierapport: Clofarabine Combined with Busulfan Provides Excellent Disease Control in Adult Patients with Acute Lymphoblastic Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation is tegen betaling op de website van Elsevier in te zien.
30 december 2004: Bron: DOWnews and Wallstreet Journal
De Europese Commissie heeft in navolging van de FDA clofarabine officieel goedgekeurd als medicijn tegen ALL = Acute Lymnfatische Leukemie bij patienten die een recidief kregen. Hier vond ik nog een recente fase II studie die de goede resultaten van clorafabine bevestigt. Eerder gaf de FDA toestemming op basis van slechts 1 fase I/II studie maar in de praktijk blijkt clorafabine goed te werken. Lees ook in dit abstract waarin kinderen die een recidef kregen na eerder behandelingen alsnog met een behandeling van clorafabine in aanmerking kwamen voor een beenmergtransplantatie.
J Clin Oncol. 2006 Apr 20;24(12):1917-23. Phase II study of clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia. Jeha S, Gaynon PS, Razzouk BI, Franklin J, Kadota R, Shen V, Luchtman-Jones L, Rytting M, Bomgaars LR, Rheingold S, Ritchey K, Albano E, Arceci RJ, Goldman S, Griffin T, Altman A, Gordon B, Steinherz L, Weitman S, Steinherz P. Department of Hematology-Oncology, St Jude Children's Research Hospital, Memphis, TN 38105, USA. sima.jeha@stjude.org
PURPOSE: To evaluate the efficacy and safety of clofarabine, a novel deoxyadenosine analog, in pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL).
PATIENTS AND METHODS: In a phase II, open-label, multicenter study, 61 pediatric patients with refractory or relapsed ALL received clofarabine 52 mg/m2 intravenously over 2 hours daily for 5 days, every 2 to 6 weeks. The median age was 12 years (range, 1 to 20 years), and the median number of prior regimens was three (range, two to six regimens).
RESULTS: The response rate was 30%, consisting of seven complete remissions (CR), five CRs without platelet recovery (CRp), and six partial remissions. Remissions were durable enough to allow patients to proceed to hematopoietic stem-cell transplantation (HSCT) after clofarabine. Median CR duration in patients who did not receive HSCT was 6 weeks, with four patients maintaining CR or CRp for 8 weeks or more (8+, 12, 37+, and 48 weeks) on clofarabine therapy alone. The most common adverse events of grade > or = 3 were febrile neutropenia, anorexia, hypotension, and nausea.
CONCLUSION: Clofarabine is active as a single agent in pediatric patients with multiple relapsed or refractory ALL. The toxicity profile is as expected in this heavily pretreated patient population. Studies exploring rational combinations of clofarabine with other agents are ongoing in an effort to maximize clinical benefit. Publication Types: Clinical Trial, Phase II Multicenter Study PMID: 16622268 [PubMed - indexed for MEDLINE]
Clofarabine Combined with Busulfan Provides Excellent Disease Control in Adult Patients with Acute Lymphoblastic Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Clofarabine Combined with Busulfan Provides Excellent Disease Control in Adult Patients with Acute Lymphoblastic Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.
Source
From the Departments of Stem Cell Transplantation and Cellular Therapy, and, , Houston, Texas.
Abstract
We investigated the safety and early disease-control data obtained with intravenous busulfan (Bu) combined with clofarabine (Clo) in patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (SCT). Fifty-one patients with median age 36 years (range 20-64) received a matched sibling (n=24), syngeneic (n=2) or matched unrelated donor transplant (n=25) for ALL in first complete remission (n=30), second complete remission (n=13), or with active disease (n=8). More than half of the patients had high-risk cytogenetic profiles as defined by the presence of t(9;22) (n=17), t(4;11) (n=3), or complex cytogenetics (n=7). Clo 40 mg/m(2) was given once daily, each dose followed by pharmacokinetically-dosed Bu infused over three hours daily for 4 days followed by hematopoietic cell infusion 2 days later. The Bu dose was based upon the drug clearance determined by a test Bu dose, 32 mg/m(2), given 48 hours prior to the high dose regimen. The target daily area under the curve (AUC) was 5,500 microMol-min for patients less than 60 years of age and 4000 microMol-min for patients ≥60 years of age. The regimen was well tolerated with 100 day non-relapse mortality (NRM) rate of 6%. With a median follow-up of 14 months among surviving patients (range, 6-28 months), the one-year overall survival (OS), disease-free survival (DFS), and non-relapse mortality (NRM) rates were 67% (95%CI: 55%-83%), 54% (95%CI: 41%-71%), and 32% (95%CI: 16%-45%), respectively. For patients transplanted in first remission, the one-year OS, DFS, and NRM rates were 74%, 64%, and 25%, respectively. The combination of Clo-Bu provides effective disease control while maintaining a favorable safety profile.
Copyright © 2012 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
- PMID:
- 22750645
- [PubMed - as supplied by publisher]
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