Status:
COMPLETED
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma
Detailed Description
Rationale: Two Food and Drug Administration drugs approved for blood cancers such as non-Hodgkin's lymphoma (NHL) include fludarabine (Fludara) and cladribine (Leustat). The drug offered in the curren...
Eligibility Criteria
Inclusion
- Must have histologically confirmed aggressive NHL
- B-cell NHL must be relapsed/ refractory
- T-cell \& NK-cell and transformed lymphoma eligible at DX
- Patients with B-cell NHL (ie, diffuse large B-cell lymphoma, mantle cell lymphoma, and Burkitt's lymphoma) must have relapsed or refractory disease after at least 1 prior therapy.
- Patients previously treated with radioimmunotherapy (ie, ibritumomab tiuxetan \[Zevalin\] or tositumomab \[Bexxar\]) or prior stem cell transplant (SCT) are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Life expectancy of at least 12 weeks.
- Laboratory values obtained ≤ 7 days prior to registration:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelets ≥ 100,000/mm3
- Total bilirubin ≤ upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 × ULN
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 × ULN
- Serum creatinine ≤ ULN
Exclusion
- No prior treatment with clofarabine.
- Full recovery from all acute toxicities associated with prior chemotherapy, radiotherapy, or immunotherapy.- Patients with active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy) are not eligible.
- Cardiac function (i.e. left ventricular ejection fraction) ≥ 50% on pretreatment radionuclide ventriculography (RVG) or echocardiogram.
- Women that are pregnant or breastfeeding.
- Known HIV disease.
- No CNS lymphoma
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00201669
Start Date
October 1 2004
End Date
June 1 2006
Last Update
December 6 2017
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210