Clinical trial · Interventional
Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
A Phase I/II Study of Veltuzumab (IMMU-106, hA20), a Humanized Anti-CD20 Monoclonal Antibody, Combined With Milatuzumab (IMMU-115, hLL1), a Humanized Anti-CD74 Monoclonal Antibody, in Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
NCT00989586CI-TRIAL-00025799completedPhase 1 / Phase 2Results postedClinicalTrials.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)
A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory B-cell NHL. The phase I study will be followed by a pilot phase II study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Correlative/Special Studies | Procedure | — | UNRESOLVED |
| Human Anti-Human Antibodies | Procedure | — | UNRESOLVED |
| milatuzumab | Biological | — | UNRESOLVED |
| Pharmacokinetics | Procedure | — | UNRESOLVED |
| Quantitative T-, B-, and NK cell subsets | Procedure | — | UNRESOLVED |
| veltuzumab | Biological | — | UNRESOLVED |
| veltuzumab and milatuzumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I
- description
- Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
- interventionNames
- Biological: milatuzumab
- Biological: veltuzumab
- Procedure: Correlative/Special Studies
- Procedure: Quantitative T-, B-, and NK cell subsets
- Procedure: Pharmacokinetics
- Procedure: Human Anti-Human Antibodies
- type
- EXPERIMENTAL
- label
- Phase II
- description
- Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including any of the following: * Marginal zone lymphoma * Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma) * Follicular lymphoma * Mantle cell lymphoma * Relapsed or refractory disease after ≥ 1 prior therapy * Patients with rituximab-refractory disease (defined as having less than a partial response to the prior rituximab-containing regimen) or rituximab-sensitive disease (defined as having a complete response or partial response to the last rituximab-containing regimen \[provided it has been ≥ 3 months since the last dose of rituximab\]) are eligible. * Age \>18 years. * Eastern Cooperative Oncology Group (ECOG)performance status 0-2. * Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥ 1000/μL * Platelets ≥ 75,000/μL * Total bilirubin ≤ 2.0 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal * Creatinine ≤ 2.0 mg/dL * Patients who have relapsed after stem cell transplant are eligible for this trial. * Patients with active Hepatitis B infection are not eligible. * Non-pregnant and non-nursing. Women of child bearing potential and men must agree to use contraception prior to study entry and for duration of study participation. * Must possess the ability to understand and the willingness to sign a written informed consent document. Phase II -Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension \>10 mm or in the case of Waldenstrom's macroglobulinemia, the presence of an IgM paraprotein level 2x the upper limit of normal. Exclusion Criteria: * Must be recovered from all toxicities from prior therapy or radiation (excluding alopecia). * No known CNS lymphoma. * History of documented human anti-globulin antibodies. * No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations. * HIV-positive patients. * Pregnant women. * Patients with secondary malignancies with exception of non-melanomatous skin cancers.
References
Publications (1)
- RESULTChristian BA, Poi M, Jones JA, Porcu P, Maddocks K, Flynn JM, Benson DM Jr, Phelps MA, Wei L, Byrd JC, Wegener WA, Goldenberg DM, Baiocchi RA, Blum KA. The combination of milatuzumab, a humanized anti-CD74 antibody, and veltuzumab, a humanized anti-CD20 antibody, demonstrates activity in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Br J Haematol. 2015 Jun;169(5):701-10. doi: 10.1111/bjh.13354. Epub 2015 Apr 7. PMID 25847298