Clinical trial · Interventional
Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
- 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 lack of funding
Summary
Brief summary (as posted)
This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before autologous stem cell transplant in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem cell transplant may kill more cancer cells.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Hodgkin Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent T-Cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory T-Cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Iodine I 131 Monoclonal Antibody BC8 | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (iodine I 131 monoclonal antibody B, autologous HCT)
- description
- Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.
- interventionNames
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Radiation: Iodine I 131 Monoclonal Antibody BC8
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant
- timeFrame
- Within 30 days post-transplant
- description
- Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD45 antigen expression must be documented on tumor specimens in all cases except HL, in whom histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells is required * Patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease * Mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1) * Patients are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.0 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission CT (SPECT)/CT tumor dosimetry (patients with disease that does not allow tumor dosimetry will be allowed on study since they still can contribute toward achieving the primary endpoint, but these patients will be given a lower priority over those with evaluable disease) * 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 * All patients eligible for therapeutic study must have a minimum of \>= 4 x10\^6 CD34/kg autologous hematopoietic stem cells harvested and cryopreserved and divided into 2 aliquots of at least \>= 2 x10\^6 CD34/kg each; patients with a history of prior autologous hematopoietic cell transplant (HCT) are only required to have \>= 2x10\^6 CD34/kg stored * Patients must have an expected survival of \> 60 days and must be free of major infection Exclusion Criteria: * Circulating human anti-mouse antibody (HAMA), to be determined before each infusion * Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab * Inability to understand or give an informed consent * Lymphoma involving the central nervous system * Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide (DLCO) \< 50% predicted, forced expiratory volume in one second (FEV1) \< 70% predicted, acquired immune deficiency syndrome \[AIDS\], etc.) * Known human immunodeficiency virus (HIV) seropositivity * Pregnancy or breast feeding * Prior allogeneic bone marrow or stem cell transplant * Prior autologous bone marrow or stem cell transplant or prior radiation therapy (RT) \> 20 Gy to a critical organ within 1 year of enrollment * Presence of circulating lymphoma cells by morphology or flow cytometry (\> 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged/unselected PBSC are to be used (patients with cryopreserved stem cells which are negative \[=\< 0.1% involved\] by flow cytometry will also be considered eligible) * Southwest Oncology Group (SWOG) performance status \>= 2.0 * Unable to perform self-care during radiation isolation * Expected survival if untreated less than 60 days
References
Publications (0)
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