A Phase I/II Open-label Study of Clofarabine in Patients With Relapsed or Refractory Diffuse Large Cell B-Cell NHL
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I Maximum Tolerated Dose
Maximum Tolerated Dose for ClofaraCohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study.bine. Starting dose of 4 mg/m2.
days 1 -28, maximum 6 cycles
Yes
Chadi Nabhan, MD
Principal Investigator
Oncology Specialists,SC
United States: Institutional Review Board
1066306 (0408)
NCT00156013
September 2005
April 2010
Name | Location |
---|---|
Oncology Specialists, SC | Park Ridge, Illinois 60068 |