Phase 2
Completed N=35
Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT00989586 ↗Enrolled (actual)
35
Serious AEs
8.6%
Results posted
Feb 2017
Primary outcomePrimary: Dose Limiting Toxicity (DLT) for Phase I Patients — 0 patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) for Phase I Patients |
— | — |
| PRIMARY Maximum Tolerated Dose (MTD)for Phase I Patients |
20 | — |
| PRIMARY Overall Objective Response Rate |
24 | — |
| SECONDARY Progression-free Survival (PFS) |
4.7 | — |
| SECONDARY Fcγ-receptor Polymorphism Response to Treatment |
— | — |
| SECONDARY Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry |
— | — |
| SECONDARY Access Pharmacokinetics Through AUC0-∞ (Area Under Curve) |
422 | — |
| SECONDARY Access Pharmacokinetics Through Cmax |
480 | — |
| SECONDARY Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA) |
1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00989586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.