Clinical trial · Interventional
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study
- 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)
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell 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 |
|---|---|---|---|
| Zevalin-BuCyE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zevalin-BuCyE
- description
- histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
- interventionNames
- Drug: Zevalin-BuCyE
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- the time from stem cell infusion to failure or death from any cause
- description
- Three year event-free survival rate would be reported.
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- from stem cell infusion to death of any cause or last follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis * Age \< 65 years old * WHO performance status (PS) of 0-2 * ANC \> 1,500/mm3, platelet \> 100,000/mm3 * Cr \< 2.0 mg% or Ccr \> 50 mL/min * Transaminase \< 3X upper normal value * Bilirubin \< 2 mg/dL * Life expectancy of at least 3 months * Written informed consent * Optimal harvest of autologous stem cells (CD34+ cells \> 5 million/kg plus 2 million/kg for back-up) Exclusion Criteria: * Prior hematopoietic stem cell transplantation * Prior RIT * Prior external radiation to \> 25% of active bone marrow * CNS involvement of non-Hodgkin's lymphoma * Serious comorbid diseases * HIV or HTLV-1 associated malignancy * History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ * Known hypersensitivity to murine antibodies/proteins * Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT * Persistent toxic side effects from prior therapy * Prior biologic or immunotherapy less than 4 weeks prior to entry on this study * Investigational drugs less than 4 weeks prior to entry on this study
References
Publications (1)
- RESULTKang BW, Kim WS, Kim C, Jang G, Lee SS, Choi YH, Lee DH, Kim SW, Kim S, Ryu JS, Huh J, Lee JS, Suh C. Yttrium-90-ibritumomab tiuxetan in combination with intravenous busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Invest New Drugs. 2010 Aug;28(4):516-22. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23. PMID 19547918