Clinical trial · Interventional
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma
NCT00131937CI-TRIAL-00019030completedPhase 2Results postedClinicalTrials.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 phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Hepatosplenic T-cell Lymphoma | Hepatosplenic T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Immunoblastic Large Cell Lymphoma | Adult Immunoblastic Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult T-cell Leukemia/Lymphoma | Adult T-Cell Leukemia/Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (sorafenib tosylate)
- description
- Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: sorafenib tosylate
Primary outcomes (1)
- measure
- Overall Response (OR) Rate
- timeFrame
- Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.
- description
- Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass \>1.5 cm in greatest diameter that has decreased by \>75%. Indeterminate bone marrow. PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed recurrent de novo or transformed diffuse large B cell lymphoma (DLBCL) or one of its variants according to WHO classification (centroblastic, immunoblastic, T-cell/histiocyte rich and anaplastic variants) * Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 * Patients must have measurable disease as defined in section 6 assessed within 4 weeks of registration * Patients must have failed one or more prior Non-Hodgkin lymphoma (NHL) chemotherapy or antibody therapy with curative intent; autologous stem cell transplant is permitted * Leukocytes \>= 2,000/mm\^3 * Absolute neutrophil count \>= 1,000/mm\^3 * Platelets \>= 75,000/ mm\^3 * Total bilirubin =\< 2.0 X normal institutional limits * Aspartate Aminotransferase (AST) =\< 2.5 X institutional upper limit of normal * Alanine Aminotransferase (ALT) =\< 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits; creatinine clearance calculated or measured at \>= 60 ml/min/1.73m\^2 if creatinine level is above institutional limits * The prothrombin time (PT)/international normalized ratio (INR) within Institutional limits of normal * Patients with underlying hypertension as defined by blood pressures averaging greater than 140/90 on two separate clinic visits are eligible if hypertension has been controlled by standard nonpharmacologic and pharmacologic therapy * Patients must be physically able to orally ingest tablets Exclusion Criteria: * Central nervous system (CNS) involvement * Previously treated with Sorafenib (BAY 43-9006) or other small molecule targeted inhibitors of mitogen-activated protein kinase (MAPK) signaling intermediates or angiogenesis (e.g. bevacizumab) * Progressed within 60 days of last therapy * Prior allogeneic stem cell transplant * Candidates for potentially curative therapy, such as hematopoietic stem cell transplantation (HSCT) * Currently receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements * Active HIV infection, because of possible pharmacokinetic interactions of anti-retroviral therapy with BAY43-9006 * Evidence of bleeding diathesis * Currently taking the cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine and phenobarbital), rifampin or St. John's Wort * Pregnant or Breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
References
Publications (0)
Data not yet available
No reference posted for this study.