Clinical trial · Interventional
Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation
Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell 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)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances. PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose
- measure
- Safety and efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation * Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks o Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis * CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following: * Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody * Flow cytometry studies * Measurable disease o More than 2 cm bidimensionally * 19 years of age and over * Performance status WHO 0-2 * Life expectancy at least 3 months * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 150,000/mm\^3 * Bilirubin less than 2.0 mg/dL * SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver) * Creatinine less than 2.0 mg/dL * Fertile patients must use effective contraception during and for 6 months after study therapy * HIV negative * At least 4 weeks since prior growth factors * At least 4 weeks since prior biologic therapy * At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas) * At least 4 weeks since prior radiotherapy * Recovered from all prior therapy * At least 4 weeks since prior immunosuppressants Exclusion Criteria: * No active CNS lymphoma * No HIV- or AIDS-related lymphoma * No transfusion dependency * No active obstructive hydronephrosis * Not pregnant or nursing/negative pregnancy test * No active infection requiring oral or IV antibiotics * No human antimurine antibody positivity * No other major medical problems * No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\]) * No prior radioimmunotherapy * No other concurrent biologic therapy of any kind * No prior fludarabine * No concurrent chemotherapy * No concurrent steroids except as maintenance for non-cancerous disease * No prior pelvic radiotherapy * No prior radiotherapy to more than 25% of estimated bone marrow reserve * No concurrent external beam radiotherapy * No other concurrent investigational drugs * No other concurrent anti-cancer therapy
References
Publications (0)
Data not yet available