A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia 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 Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00496132
• Other study ID #: ACO4198g
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 3, 2007
• Last updated: June 26, 2017
• Start date: August 27, 2007
• Est. completion date: June 17, 2009

Study information

• Verified date: June 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• 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 chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 17, 2009
• Est. primary completion date: June 17, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented history of histologically confirmed B-cell CLL

• Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen

• Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL

• For patients of reproductive potential (males and females), use of a reliable means of contraception

• For females of childbearing potential, a negative serum pregnancy test

Exclusion Criteria:

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

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

• Current or recent CLL treatment

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

• Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL

• Use of hematopoietic growth factors or RBC and/or platelet transfusions

• 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

• History of cancer other than CLL)

• Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics

• 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

• Positive hepatitis B or C serology

• Positive human immunodeficiency virus (HIV) serology

• Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing

• Pregnancy or lactation

• CNS leukemia

• Recent major surgery, other than diagnostic surgery

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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
Secondary	Pharmacokinetic parameters; CD19-positive B-cell counts		Length of study
Secondary	Overall response rate and progression-free survival (Phase II only)		Length of study