Clinical trial · Interventional
Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell 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): Closed early due to lack of funding
Summary
Brief summary (as posted)
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.
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 |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| CD20-Positive Neoplastic Cells Present | — | UNRESOLVED | — |
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Indolent Non-Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Mature B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein | Biological | — | UNRESOLVED |
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Carmustine | Drug | Carmustine | ALIAS |
| Clearing Agent | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Indium In 111-DOTA-Biotin | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (PRIT)
- description
- B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17. CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15. RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14. BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2. STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.
- interventionNames
- Biological: Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Carmustine
- Drug: Clearing Agent
- Drug: Cytarabine
- Drug: Etoposide
- Radiation: Indium In 111-DOTA-Biotin
- Other: Laboratory Biomarker Analysis
- Drug: Melphalan
- Procedure: Peripheral Blood Stem Cell Transplantation
- Other: Pharmacological Study
- Radiation: Yttrium Y 90-DOTA-Biotin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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) as well as other select high-risk lymphomas (e.g., Burkitt?s, double hit diffuse large B-cell lymphoma \[DLBCL\], transformed indolent B-cell non-Hodgkin lymphoma \[B-NHL\], etc.) 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, who may have a total bilirubin above 1.5 mg/dL * All patients eligible for therapeutic study must have (\>= 2 x 10\^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved * Patients must have an expected survival of \> 60 days and must be free of major infection * Patients of childbearing potential must agree to abstinence or the use of effective contraception * DONOR SELECTION: Not applicable; this protocol employs autologous transplantation, utilizing the patient?s own hematopoietic stem cells obtained from either the peripheral blood or bone marrow Exclusion Criteria: * Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y 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, both kidneys) within 1 year of the treatment date * Active central nervous system lymphoma * 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, patient on supplemental oxygen, acquired immune deficiency syndrome \[AIDS\], etc.) * Pregnancy or breast feeding * Prior bone marrow or stem cell transplant * Southwest Oncology Group (SWOG) performance status \>= 2.0 * Known sensitivity to kanamycin and other aminoglycosides; patients with known hypersensitivity to kanamycin or any other aminoglycoside antibiotic will be excluded
References
Publications (0)
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