Clinical trial · Interventional
Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT02840539CI-TRIAL-00064846BATMANcompletedPhase 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)
The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.
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 |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib, Cytarabine, Dexamethasone, Pegteograstim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
- interventionNames
- Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Primary outcomes (1)
- measure
- Overall response
- timeFrame
- within 28 days after the last cycle of treatment
- description
- Lugano classification
Secondary outcomes (3)
- measure
- Complete response
- timeFrame
- within 28 days after the last cycle of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed mantle cell lymphoma * Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents * ECOG performance status 2 or less * Adequate hematologic, hepatic, and renal function i. White blood cells ≥ 3,000 /ul ii. Absolute neutrophil count ≥ 1,000 /ul iii. Platelets ≥ 50,000 /ul iv. Hemoglobin ≥ 9.0 g/dL v. Total bilirubin \< 2 times upper limit of normal vi. AST, ALT \< 2.5 times upper limit of normal vii. Serum creatinine \< 1.5 times upper limit of normal Exclusion Criteria: * Previously treated with 4 or more lines of chemotherapy with or without immunologic agents * Previously treated with bortezomib * Treated with a cytarabine-containing regimen as the last line and within 6 months before registration * Other cancer diagnosed within 5 years before registration * Uncontrolled symptomatic CNS involvement of mantle cell lymphoma * Uncontrolled systemic infection * Inherited immunodeficiency disease or AIDS * Pregnancy * Breast-feeding * Peripheral neuropathy of grade 3 or higher * Other health conditions considered to be inappropriate for this trial in the primary physician's opinion
References
Publications (2)
- BACKGROUNDRobak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096. PMID 25738670
- DERIVEDShin J, Lee JY, Lee GW, Kim WS, Park Y, Do YR, Kim DS, Kim KH, Choi YS, Byun JM, Hong J, Kim I, Yoon SS, Koh Y. Phase II study of bortezomib, cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma. Br J Haematol. 2023 Sep;202(6):e54-e57. doi: 10.1111/bjh.18965. Epub 2023 Jul 5. No abstract available. PMID 37408333