Clinical trial · Interventional
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
NCT01647971CI-TRIAL-00062276completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
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 |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ublituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ublituximab
- description
- Phase I: 4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 \& 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply.
- interventionNames
- Drug: Ublituximab
Primary outcomes (2)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- Subjects will be followed for 4 weeks
- description
- Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or Refractory B-cell Lymphoma * Measurable or Evaluable Disease * Previously treated with at least one line of rituximab or a rituximab based therapy * Patients ineligible for high dose or combination chemotherapy + stem cell transplant * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology Exclusion Criteria: * Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry * Prior autologous or allogeneic stem cell transplantation within 3 months of study entry * History of severe hypersensitivity or anaphylaxis to prior rituximab * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.