Clinical trial · Interventional
Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma
- 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: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DI-Leu16-IL2 immunocytokine | Biological | — | UNRESOLVED |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays. Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays. Treatment repeats every 6-8 weeks for up to a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: DI-Leu16-IL2 immunocytokine
- Biological: rituximab
- Other: flow cytometry
- Other: immunohistochemistry staining method
- Other: pharmacological study
- Other: laboratory biomarker analysis
- Other: enzyme-linked immunosorbent assay
- Genetic: reverse transcriptase-polymerase chain reaction
Primary outcomes (3)
- measure
- Maximum tolerated dose of DI-Leu16-IL2
- timeFrame
- 6 weeks post cycle 1 of treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion * Patients with CD20-expressing B cell NHL that is relapsed or refractory to standard therapy; CLL/SLL with peripheral blood leukemia/lymphoma cells and high-grade lymphomas (i.e., lymphoblastic lymphoma/Burkitt lymphoma) are excluded * Patients must have received prior Rituxan * Measurable disease; in the absence of lymphadenopathy, splenomegaly with defects or measurable extramedullary disease is acceptable; however, bone marrow involvement alone will not be included in the study * Age \>=18 years and \<=65 physiologic years of age * KPS \>= 70% * Life expectancy \>= 12 weeks * Serum creatinine =\< 1.5 mg/dl * Total WBC \>= 3000/ul or absolute neutrophil count (ANC) \>= 1000/ul * Lymphocyte count \>= 0.2 x 10\^3/ul * Platelet count \>= 75,000/ul * Hematocrit \>= 25% or hemoglobin \>= 9 g/100 ml * Alanine aminotransferase (ALT) =\< 2.5 x UNL * Aspartate aminotransferase (AST) =\< 2.5 x UNL * Total bilirubin (TBili) \< 1.5 x UNL * Sodium, potassium, and phosphorus within normal limits * Chest x ray (CXR) within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema; if results are questionable, subjects would have additional lung function testing to exclude clinically relevant restriction or obstruction; subjects must have an FEV-1 and DLCO of at least 65% and 50% of expected, respectively * Electrocardiogram (12-lead ECG) * Echocardiogram (or MUGA) with normal left ventricular function * Cardiac stress test (e.g., stress thallium scan, stress echocardiography) with normal results if subject is suspected to have coronary artery disease * Fasting blood glucose (FBG) \< 160 and hemoglobin (Hgb) A1C \< 7% for subjects with diabetes mellitus (DM) or borderline DM * Women of procreative potential must have negative pregnancy test within the 2-week screening phase prior to Cycle 1, and all subjects of procreative potential must use adequate birth control throughout the study; subjects of procreative potential are defined as any fertile male, and any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy) or is not post-menopausal, defined as age-related amenorrhea \>= 12 months * Provide written informed consent prior to any screening procedures Exclusion * Evidence of CNS lymphoma or lymphomatous meningitis * Prior treatment with IL-2 * Type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusion of rituximab * Pregnant or lactating female * An immediate need for palliative radiotherapy or systemic corticosteroid therapy * Known intercurrent infections (including hepatitis C virus \[HCV\] and HIV or other conditions), or clinical evidence of these conditions * Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcHb) or hepatitis B surface antigen (HbsAg); (subjects who are sero-positive only, i.e., surface antibody positive \[HbsAg\], are permitted) * Other significant active infection * Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1 * Uncontrolled hypertension (diastolic \>= 100 mmHg) or hypotension (systolic =\< 90 mmHg) * History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias * On ECG: a marked baseline prolongation of QT/QTc interval (\> grade 2 QTc interval \> 470 milliseconds) * History of medically significant ascites requiring repetitive paracentesis * Previous diagnosis of Addison's disease * Previous diagnosis of autoimmune disease (exceptions: subjects with autoimmune thyroiditis or vitiligo may be enrolled) * Organ transplant recipient * History of prior therapy or a serious, uncontrolled medical disorder that in the investigator's opinion would impair participation in the study * Known hypersensitivity to Tween-80 or human immunoglobulin * Legal incapacity or limited legal capacity * Patients with bulky lymph nodes (\>= 10cm) or marked splenomegaly (i.e., extending into pelvis or crossing the midline) * Positive anti-DI-Leu16-IL2 antibody assay (where positive is defined as \> 10% of the radiolabeled DI-Leu16-IL2 reactive with the subject's serum)
References
Publications (0)
Data not yet available