NHL, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Intermediate-Grade, Lymphoma, Large-Cell, Lymphoma, Low-Grade, Lymphoma, Mixed-Cell, Lymphoma, Small-Cell, Leukemia, Lymphocytic, Chronic, Leukemia, B-Cell, Chronic, Leukemia, Prolymphocytic, Leukemia, Small Lymphocytic, Lymphoma, Small Lymphocytic, Lymphoma, Lymphoplasmacytoid, CLL, Lymphoplasmacytoid Lymphoma, CLL, CLL, SLL
Conditions
Keywords
humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously
Brief summary
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.
Detailed description
The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL
Interventions
BIOLOGICALveltuzumab
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/tolerability | over 2 years after treatment | safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years. |
Countries
United States
Outcome results
None listed