Status and phase
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About
This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).
Full description
The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies, with numerous responses observed in heavily pre-treated patients with relapsed/refractory ALL or AML. Dose escalation of clofarabine in patients with solid tumors and lymphoproliferative disorders has been limited because grade 3 and 4 myelosuppression was considered acceptable in patients with acute leukemia, provided that hematologic recovery occurred within 6 weeks of therapy , and dose escalation has proceeded as high as 40 mg/m2 in this patient population. Furthermore, no responses were observed in a recent trial in which patients with relapsed CLL were treated with clofarabine 2 mg/m2, an indolent B-cell lymphoproliferative disorder indicating that low doses are likely to be ineffective in patients with aggressive NHL. (Personal Communication with ILEX Products, INC.)
This Phase I/II study will evaluate escalating doses of clofarabine in patients with relapsed and refractory diffuse large cell B-cell NHL starting at a dose of 4 mg/m2/day for 5 consecutive days and repeated every 28 days for a maximum of 6 cycles. This dosing regimen should be evaluated in this patient population because there is no standard therapy at relapse and grade 3 and 4 myelosuppression is frequently observed with traditional NHL salvage. Additionally, patients will receive granulocyte colony stimulating factors at the discretion of the investigator. Antifungal and antibacterial prophylaxis will be administered to minimize the risk of infection.
Enrollment
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Inclusion criteria
Adult patients who are at least 18 years old with histology confirmed diffuse large cell B-cell NHL who have failed prior systemic chemotherapy with or without monoclonal antibody-based therapies.
Measurable disease determined by Ct or PET scans or bone marrow involvement, defined as lesions that can be accurately measured in two dimensions by CT or PET scan with the longest diameter accurately as greater than or equal to 1.0 cm or palpable lesions with both diameters greater than or equal to 2.0 cm. PET scan measurable disease is defined based on SUV value as determined by nuclear medicine evaluation.
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1,or 2.
Life expectancy greater than 12 weeks.
Laboratory values obtained less than or equal to 14 days prior to registration:
Cardiac function on pretreatment MUGA scan or echocardiogram that is considered normal by institutional standards.
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Male and female patients must use an effective contraceptive method during the study and for a minium of 6 months after study treatment.
Exclusion criteria
Primary purpose
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33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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