Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma

Gilead Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lymphoma, Diffuse

Non-Hodgkin's Lymphoma

Lymphoma, Diffuse, Mixed Lymphocytic-Histiocytic

Treatments

Drug: veltuzumab

Study type

Interventional

Funder types

Industry

Identifiers

IM-T-hA20-01EU

Details and patient eligibility

About

This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, >18 years old
Histological diagnosis of CD20+ B-cell NHL (all grades) by WHO lymphoma criteria
Failed at least one prior standard chemotherapy regimen for NHL
Failed rituximab treatment for relapsed NHL
Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension
Adequate performance status (>70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
Adequate hematologic status, without ongoing transfusional support (hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L)
Adequate renal and hepatic function, defined as: creatinine ≤ 1.5 x Institution Upper Limit of Normal (IULN), bilirubin ≤ 1.5 x IULN, AST and ALT ≤ 2.5 x IULN
Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 2.0, including recovery from all acute toxicities incurred as a result of previous surgery, radiotherapy or chemotherapy, whether investigational or conventional.
At least 6 months beyond previous rituximab treatment, 12 weeks beyond autologous stem cell transplant, 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
Ability to provide signed, informed consent

Exclusion criteria

Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly hA20 infusion.
Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
Prior radioimmunotherapy, including Zevalin or Bexxar,
Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
Pleural effusion with positive cytology for lymphoma Known to be HIV positive, or hepatitis B or C positive
Known autoimmune disease or presence of autoimmune phenomena.
Evidence of infection or requiring antibiotics within 5 days.
Corticosteroid use within 2 weeks
Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of studyprocedures and follow-up examinations