Clinical trial · Interventional
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
NCT00182637CI-TRIAL-00046368completedPhase 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)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell 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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bortezomib
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Overall Response Rate After 2 Courses of Treatment
- timeFrame
- 2 months
Secondary outcomes (2)
- measure
- Time to Progression
- timeFrame
- 2 years
- measure
- Toxicity
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome * Stage IB-IV disease * Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy * Measurable disease by radiological imaging or clinical finding * Age Over 18 * Performance status Karnofsky 70-100% * Hematopoietic * WBC \> 2,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 75,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) * AST and ALT \< 3 times ULN * Renal * Creatinine \< 1.5 times ULN * Creatinine clearance ≥ 30 mL/min * Negative pregnancy test * Fertile patients must use effective contraception * More than 3 months since prior high-dose chemotherapy * More than 30 days since prior and no other concurrent investigational drugs Exclusion Criteria: * history of myelodysplastic syndromes * evidence of CNS disease * pregnant or nursing * peripheral neuropathy ≥ grade 2 * hypersensitivity to bortezomib, boron, or mannitol * serious medical condition or psychiatric illness that would preclude study participation * concurrent immunotherapy * concurrent chemotherapy * concurrent steroid dose \> 10 mg/day of prednisone or its equivalent * concurrent radiotherapy * concurrent surgery for the malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.