Clinical trial · Interventional
Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Ibritumomab Tiuxetan and High-Dose Melphalan as Conditioning Regimen Before Autologous Stem Cell Transplantation for Elderly Patients With Lymphoma in Relapse or Resistant to Chemotherapy. A Multicenter Phase I Trial
- 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: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell transplant helps stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed or not responded to 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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell harvesting and transplantation | Procedure | — | UNRESOLVED |
| ibritumomab tiuxetan | Drug | Ibritumomab Tiuxetan | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| vinorelbine tartrate / G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zevalin, Rituximab, Melphalan
- interventionNames
- Drug: ibritumomab tiuxetan
- Drug: rituximab
- Drug: melphalan
- Drug: vinorelbine tartrate / G-CSF
- Procedure: autologous hematopoietic stem cell harvesting and transplantation
Primary outcomes (1)
- measure
- Dose-limiting toxicity of high-dose melphalan in combination with yttrium Y 90 ibritumomab tiuxetan
- timeFrame
- within 8 weeks after application of melphalan
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- 100 days (+/- 5 days) after reinfusion of stem cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma of any type * CD20-positive disease * Achieved partial or complete response to salvage treatment for relapse or refractory disease within the past 10 weeks * Must have an indication for autologous stem cell transplantation * Bone marrow infiltration \< 25% * No evidence of CNS involvement PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Bilirubin ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST ≤ 2 times ULN * Creatinine clearance \> 50 mL/min * No clinically significant cardiac disease, including any of the following: * Unstable angina pectoris * Significant arrhythmia * Myocardial infarction within the past 3 months * LVEF \> 50% * No clinically significant urinary tract obstruction * No clinically significant pulmonary disease * No serious underlying medical condition that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated in situ cervical cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 30 days since prior participation in another clinical trial * No prior stem cell transplantation * No prior radiolabeled antibodies, including for induction of disease remission * No prior radiotherapy to ≥ 25% of the bone marrow * No concurrent radiotherapy * No other concurrent anticancer drugs * No other concurrent investigational drugs
References
Publications (1)
- RESULTVoegeli M, Rondeau S, Berardi Vilei S, Lerch E, Wannesson L, Pabst T, Rentschler J, Bargetzi M, Jost L, Ketterer N, Bischof Delaloye A, Ghielmini M. Y90 -Ibritumomab tiuxetan (Y90 -IT) and high-dose melphalan as conditioning regimen before autologous stem cell transplantation for elderly patients with lymphoma in relapse or resistant to chemotherapy: a feasibility trial (SAKK 37/05). Hematol Oncol. 2017 Dec;35(4):576-583. doi: 10.1002/hon.2348. Epub 2016 Sep 28. PMID 27677906