Clinical trial · Interventional
High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to insufficient funding
Summary
Brief summary (as posted)
This phase II trial studies the side effects and how well high-dose yttrium-90 (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation \[CD\]20) followed by fludarabine phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them with less effect on normal cells. Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. However, high-dose radiolabeled antibodies also destroy healthy blood cells in the patient's body. When healthy stem cells from a donor are infused into the patient (stem cell transplant), they may help the patient's body replace these blood cells. Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate, TBI, and donor PBSCT may be an effective treatment for patients with B-cell lymphoma.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-Transplant Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Burkitt Lymphoma | Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Refractory B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Burkitt Lymphoma | Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Cyclosporine | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Fludarabine Phosphate | Drug | Fludarabine | ALIAS |
| Indium In-111 Ibritumomab Tiuxetan | Radiation | — | UNRESOLVED |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiolabeled antibody, TBI, allogeneic PBSCT)
- description
- Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).
- interventionNames
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Cyclosporine
- Drug: Fludarabine Phosphate
- Radiation: Indium In-111 Ibritumomab Tiuxetan
- Drug: Mycophenolate Mofetil
- Other: Pharmacological Study
- Biological: Rituximab
- Radiation: Total-Body Irradiation
- Radiation: Yttrium Y-90 Ibritumomab Tiuxetan
- Drug: Fludarabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of aggressive B-cell lymphoma (diffuse large B-cell lymphoma \[DLBCL\], Burkitt lymphoma \[BL\], etc.) expressing the CD20 antigen and have failed at least one prior standard systemic therapy * Patients must have relapsed after high-dose therapy and autologous transplantation or be ineligible for high-dose therapy and autologous transplantation; patients that have failed autologous transplantation are those with persistent disease \> 30 days after transplant; those ineligible for autologous transplant include those with chemoresistant disease (i.e., patients who have not achieved a partial response or better with their most recent chemotherapy regimen), are expected to have a poor outcome from autologous transplant (e.g., DLBCL relapsing within one year of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone \[R-CHOP\]-like chemotherapy, double hit lymphoma, v-myc myelocytomatosis viral oncogene homolog (avian) positive \[MYC+\] lymphoma, persistent positron emission tomography \[PET\] positivity after chemotherapy), are unable to collect sufficient or tumor-free autologous stem cells per Seattle Cancer Care Alliance (SCCA) standard practice, are unable to tolerate the high-dose autologous conditioning regimens, or who refuse a high-dose autologous transplant regimen * Creatinine (Cr) \< 2.0 * Bilirubin \< 1.5 mg/dL with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) * Patients must have an expected survival without treatment of \> 60 days and must be free of major infection including human immunodeficiency virus (HIV) * Patients must have an HLA-identical related or HLA-matched unrelated donor Exclusion Criteria: * Receipt of systemic anti-lymphoma therapy withinthe following intervals prior to the therapeutic 90Y-ibritumomab tiuxetan dose: * \< 30 days for intravenously-administered cytotoxic chemotherapy and/or monoclonal antibodies * \< 5 half-lives for all other anti-cancer agents (e.g., targeted therapies, corticosteroids, immunomodulatory agents, etc.) * Inability to understand or give an informed consent * Active central nervous system lymphoma * Pregnancy * Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment * Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) performance score \>= 2 * High-dose chemotherapy or external beam radiation therapy to lung, liver, or kidneys \> 20 Gy within the previous 100 days prior to therapeutic 90Y-ibritumomab tiuxetan dose * Medical condition that would contraindicate allogeneic transplantation as per standard practice guidelines (e.g., impaired cardiopulmonary function, hepatitis, etc)
References
Publications (0)
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