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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00596804

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Lymphoma, Diffuse Lymphoma, Diffuse, Mixed Lymphocytic-Histiocytic	Drug: veltuzumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Safety of hA20 with this administration schedule and dosing [first 12 weeks, then over 2 years]
tolerance of hA20 with this administration schedule and dosing [first 12 weeks]
immunogenicity of hA20 with this administration schedule and dosing [first 12 weeks, as needed over 2 years]

Secondary Outcome Measures

Pharmacodynamics of hA20 [first 12 weeks, then up to 2 years]
pharmacokinetics hA20 [first 12 weeks, then up to 2 years]
assess efficacy [4 and 12 weeks, then every 3 months for 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service Des Maladies Du Sang	Lille	Cedex	France	59037
2	Centre hospitalier Lyon	Lyon	Pierre Benite Cedex	France	69495
3	University of Leicester	Leicester		United Kingdom	LE1 9HN