Clinical trial · Interventional
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma
NCT00201669CI-TRIAL-00030695completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- up to two years
Secondary outcomes (4)
- measure
- Determine the toxicity of clofarabine administered in conjunction with growth factor support in patients with relapsed/refractory aggressive NHL.
- timeFrame
- up to two years
- measure
- determine the effect of clofarabine on T-, B-, and natural killer (NK)-cell subsets and quantitative immunoglobulin levels after prolonged administration of clofarabine in patients with NHL.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.