Clinical trial · Interventional
Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma
A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older
- 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 phase I trial studies the side effects and best dose of fludarabine (fludarabine phosphate) when given together with iodine I 131 tositumomab in treating older patients who are undergoing an autologous or syngeneic stem cell transplant for relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 tositumomab together with fludarabine followed by autologous stem cell transplant may be an effective treatment for NHL
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Immunoblastic Large Cell Lymphoma |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| iodine I 131 tositumomab | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemoradioimmunotherapy)
- description
- Patients receive a dosimetric dose of iodine I 131 tositumomab IV over 40-60 minutes on day -24 followed by gamma camera imaging over the next 6 days. Patients then receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes on day -14. Patients also receive fludarabine phosphate IV QD on days -11 to -9 OR days -11 or -7. Patients undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0.
- interventionNames
- Drug: fludarabine phosphate
- Procedure: peripheral blood stem cell transplantation
- Radiation: iodine I 131 tositumomab
- Other: laboratory biomarker analysis
- Other: flow cytometry
- Genetic: polymerase chain reaction
Primary outcomes (1)
- measure
- Maximum tolerated dose/dose limiting toxicity
- timeFrame
- Up to 30 days post-transplant
- description
- Assessed according to Bearman scale for Regimen-Related Toxicities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients * Creatinine (Cr) \< 2.0 * Bilirubin \< 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, whom may have a total bilirubin above 1.5 mg/dL * All patients eligible for therapeutic study must have (\>= 2x10\^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved, or this number of cells harvested from a syngeneic donor * Patients must have an expected survival of \> 60 days and must be free of major infection * DONOR: Syngeneic donors must be confirmed syngeneic by ABO typing, human leukocyte antigen (HLA) typing, and variable number tandem repeat (VNTR) analysis * DONOR: Syngeneic donors must meet eligibility under Standard Practice Guidelines/Standard Treatment Exclusion Criteria: * Circulating anti-mouse antibody (HAMA) (to be determined before both dosimetry and therapy) * Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose * Inability to understand or give an informed consent * Prior radiation \> 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, \> 25% of red marrow) * Central nervous system lymphoma * Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusing capacity (DLCO) \< 50% predicted, patient on supplemental oxygen, acquired Immunodeficiency syndrome \[AIDS\], etc.) * Pregnancy * Prior bone marrow or stem cell transplant * South West Oncology Group (SWOG) performance status \>= 2 * Unable to perform self-care during radiation isolation * Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well differentiated lymphocytic lymphoma
References
Publications (1)
- DERIVEDGopal AK, Gooley TA, Rajendran JG, Pagel JM, Fisher DR, Maloney DG, Appelbaum FR, Cassaday RD, Shields A, Press OW. Myeloablative I-131-tositumomab with escalating doses of fludarabine and autologous hematopoietic transplantation for adults age >/= 60 years with B cell lymphoma. Biol Blood Marrow Transplant. 2014 Jun;20(6):770-5. doi: 10.1016/j.bbmt.2014.02.004. Epub 2014 Feb 12. PMID 24530971