Status:
COMPLETED
Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
Beth Christian
Collaborating Sponsors:
Gilead Sciences
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
A phase I/II study of veltuzumab combined with milatuzumab in relapsed and refractory non-Hodgkin's lymphoma. Both agents are well-tolerated in early phase clinical testing with infusion reactions as ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00989586
Start Date
September 1 2009
End Date
September 1 2015
Last Update
February 6 2017
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210