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

NCT00496132 | Terminated Phase 1

• 1 other identifier: ACO4198g
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL; Leukemia; Lymph

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities and adverse events

  Length of study

Secondary Outcomes (2)

• Pharmacokinetic parameters; CD19-positive B-cell counts

  Length of study

• Overall response rate and progression-free survival (Phase II only)

  Length of study

Study Arms (1)

1

EXPERIMENTAL

Drug: PRO131921

Interventions

PRO131921 DRUG

Escalating doses by IV infusion

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

PRO131921 monoclonal antibody

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bill Ho, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: August 27, 2007
• Primary Completion: June 17, 2009
• Study Completion: June 17, 2009
• Last Updated: July 2, 2017

Record last verified: 2017-06