Clinical trial · Interventional
Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
- 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 aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed 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 |
|---|---|---|---|
| Yttrium 90 Ibritumomab Tiuxetan ( Zevalin ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response rate
Secondary outcomes (1)
- measure
- Survival Data, adverse events, molecular response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>=18 to \<=70 years 2. Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and: * Expressing the CD 20 antigen * ECOG performance 0-2 * Written informed consent 3. Prior collection of at least 2.5x10\^6 CD34-positive peripheral blood stem cells/kg. Exclusion Criteria: 1. Abnormal renal function (Creatinine \>2.5x upper limit of normal (ULN) 2. Abnormal hepatic function (Bilirubin \>2xULN, ALT/AST \>3x ULN) 3. Cardiac ejection fraction \<40% 4. Severe defects in pulmonary function tests (DLCO\<70% predicted, FEV1, FVC\<60% predicted) or receiving continuous oxygen 5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy. 6. Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment 7. Prior radiotherapy to \>25% of the bone marrow or \>20 Gy to critical organ (lung, liver, kidney, spinal cord). 8. CNS lymphoma 9. Ongoing infection 10. Prior treatment with radioimmunotherapy
References
Publications (0)
Data not yet available