A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00452127
• Other study ID #: ACO3967g
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 23, 2007
• Last updated: January 18, 2013
• Start date: May 2007

Study information

• Verified date: January 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Signed informed consent

• Ability and willingness to comply with the requirements of the study protocol

• Age = 18 years

• Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL

• Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of =6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen

• Bi-dimensionally measurable disease, with at least one lesion >1.5 cm in its largest dimension

• Absolute B-cell count =LLN at screening (Phase I only)

• ECOG performance status of 0, 1, or 2

• For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment

• For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment

Exclusion Criteria:

• Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)

• Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment

• Current or recent lymphoma treatment

• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies

• Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders

• Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination

• Untreated or persistent/recurrent malignancy (other than lymphoma)

• Known active bacterial, viral, fungal, mycobacterial, or other infection

• A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening

• History of recurrent significant infection or bacterial infections

• Positive hepatitis B or C serology

• Positive human immunodeficiency virus (HIV) serology

• Pregnancy or lactation

• Central nervous system lymphoma

• Recent major surgery within 4 weeks of screening, other than diagnostic surgery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• PRO131921
Escalating doses by IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities and adverse events		Length of study	No
Secondary	Pharmacokinetic parameters; CD19-positive B-cell counts		Length of study	No
Secondary	Overall response; and progression-free survival (Ph. 2 only)		Length of study	No