Clinical trial · Interventional
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
NCT00546793CI-TRIAL-00053282completedPhase 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 if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia, B-Cell, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Prolymphocytic | Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia, Small Lymphocytic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Intermediate-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Large-Cell | Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| veltuzumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- veltuzumab
- description
- veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
- interventionNames
- Biological: veltuzumab
Primary outcomes (1)
- measure
- Safety/tolerability
- timeFrame
- over 2 years after treatment
- description
- safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL) * Either previously untreated or relapsed * Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria Exclusion Criteria: * Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification) * Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression). see full protocol for additional criteria
References
Publications (9)
- BACKGROUNDMorschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a second-generation humanized anti-CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s.
- BACKGROUNDMorschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon M, Coleman M,. Horne H, Teoh N, Wegener WA, Goldenberg DM. Low doses of humanized anti-CD20 antibody, IMMU-106 (hA20), in refractory or recurrent NHL: Phase I/II results. 2007 ASCO Annual Meeting.Proceedings; 25/18S Part I of II:449s.
- BACKGROUNDStein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78. doi: 10.1158/1078-0432.ccr-03-0493. PMID 15102696
- BACKGROUNDSapra P, et al. Preclinical pharmacology and toxicology of humanized anti-B-cell antibodies (anti-CD22 and anti-CD20) in cynomolgus monkeys (CM). (Abstract #1471) Blood 2005; 106/11:424a.
- BACKGROUNDStein R, et al. Mechanisms of anti-lymphoma effects of a new humanized anti-CD20 monoclonal antibody, IMMU-106. (Abstract No. 4917) Blood 2003; 102/11:
- BACKGROUNDGoldenberg DM, et al. Characterization and preclinical efficacy of hA20, a humanized anti-CD20 monoclonal antibody, for the treatment of NHL. (Abstract #2393) Proceedings of ASCO 2003; 22:595
- BACKGROUNDGoldenberg DM, et al. Characterization of new, chimeric and humanized, anti-CD20 monoclonal antibodies, cA20 and hA20, with equivalent efficacy to rituximab in-vitro and in xenografted human non-Hodgkin's lymphoma. (Abstract #2260) Blood 2002; 100/11:575a-576a.
- DERIVEDKalaycio ME, George Negrea O, Allen SL, Rai KR, Abbasi RM, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab: a phase I study in chronic lymphocytic leukemia. Leuk Lymphoma. 2016;57(4):803-11. doi: 10.3109/10428194.2015.1085531. Epub 2015 Oct 19.