Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I Trial Combining IDEC-Y2B8 And High-Dose Beam Chemotherapy With Hematopoietic Progenitor Cell Transplant In Patients With Relapsed Or Refractory 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: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory 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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: Carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: peripheral blood stem cell transplantation
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose of absorbed radiation to critical organs delivered with this combination of study treatments
- timeFrame
- From first study treatment until 30 days after last study treatment.
- description
- Dose limiting toxicities observed during and up to 30 days after the last study treatment resulting in the determination of the maximum tolerated dose of absorbed radiation to critical organs delivered by Y2B8 in combination with high-dose BEAM chemotherapy with autologous mobilized peripheral blood progenitor cell transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed B-cell non-Hodgkin's lymphoma * Relapsed or refractory disease * CD20-positive disease * Must have received at least 1 prior treatment regimen * Complete remission with prior conventional salvage chemotherapy is allowed * No more than 25% lymphoma in bone marrow * No circulating malignant cells on blood smear * No CNS involvement by lymphoma * No HIV- or AIDS-related lymphoma PATIENT CHARACTERISTICS: Age * Over 17 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 Hepatic * Transaminases less than 2 times normal Renal * Creatinine clearance greater than 50 mL/min Cardiovascular * LVEF at least 45% Pulmonary * Corrected DLCO at least 70% of predicted * FEV\_1 or FVC greater than 60% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No serious nonmalignant disease or other condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior rituximab and recovered * No other prior murine antibodies * No prior stem cell transplantation * No prior radioimmunoconjugate therapy Chemotherapy * See Disease Characteristics * More than 6 weeks since prior nitrosoureas or mitomycin and recovered Endocrine therapy * No concurrent systemic corticosteroids Radiotherapy * Recovered from prior radiotherapy * No prior external beam irradiation to more than 25% of the active bone marrow Surgery * More than 4 weeks since prior major surgery and recovered Other * More than 3 weeks since prior anticancer therapy
References
Publications (1)
- RESULTWinter J, Inwards D, Spies S, et al.: Zevalin® (90YZ) doses >.5 mCi/kg may be combined with high-dose beam and autotransplant (ASCT). [Abstract] Ann Oncol 16 (Suppl 5): A-215, v100, 2005.